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令和 5年11月21日作成 令和6年3月27日訂正(*)
一般的名称及び販売名
一般的名称： 治療用電気手術器 販売名 ： Valleylab FT10 エネルギープラットフォーム
対象ロット、数量及び出荷時期
製品番号 ： VLFT10GEN 対象シリアル： T0A38592DX T0A38609DX T0A38618DX T0A38619DX T0A38625DX T0A38672DX T0A38685DX T0A38786DX T0A39167DX T0A39169DX T0A39170DX T0A39172DX T0A39174DX T0A39177DX T0A39182DX T0A39187DX T0A39197DX T0A39200DX T0A39202DX T0A39206DX T0A39217DX T0A39232DX T0A39320DX T0A39321DX T0A39322DX T0A39327DX T0A39328DX T0A39329DX T0A39330DX T0A39331DX T0A39334DX T0A39335DX T0A39336DX T0A39337DX T0A39338DX T0A39339DX T0A39340DX T0A39341DX T0A39642DX T0A39646DX T0A39647DX T0A39648DX T0A39649DX T0A39650DX T0A39651DX T0A39652DX T0A39653DX T0A39654DX T0A39657DX T0A39659DX T0A39662DX T0A39663DX T0A39664DX T0A39665DX T0A39666DX T0A39667DX T0A39668DX T0A39669DX T0A39670DX T0A39671DX T0A39672DX T0A39673DX T0A39676DX T0A39677DX T0A39678DX T0A39681DX T0A39682DX T0A39684DX T0B39841DX T0B39842DX T0B39843DX T0B39844DX T0B39845DX T0B39850DX T0B39851DX T0B39852DX T0B39853DX T0B39856DX T0B39857DX T0B39858DX T0B39859DX T0B39860DX T0B39867DX T0B39868DX T0B39869DX T0B39871DX T0B39874DX T0B39875DX T0B39876DX T0B39878DX T0B39879DX T0B39880DX T0B39882DX T0B39883DX T0B39884DX T0B39885DX T0B39886DX T0C40076DX T0C40077DX T0C40078DX T0C40079DX T0C40086DX T0C40087DX T0C40088DX T0C40090DX T0C40091DX T0C40092DX T0C40094DX T0C40095DX T0C40096DX T0C40097DX T0C40099DX T0C40100DX T0C40101DX T0C40105DX T0C40106DX T0C40108DX T0C40110DX T0C40111DX T0C40112DX T0C40113DX T0C40114DX T0C40364DX T0C40365DX T0C40368DX T0C40370DX T0C40371DX T0C40372DX T0C40373DX T0C40374DX T0C40375DX T0C40376DX T0C40377DX T0C40378DX T0C40395DX T0C40401DX T0C40402DX T0C40403DX T0C40404DX T0C40405DX T0C40406DX T0C40407DX T0C40408DX T0C40410DX T0C40411DX T0C40412DX T0C40413DX T0C40415DX T0C40416DX T0C40418DX T0C40419DX T0C40421DX T0C40423DX T0C40722DX T0C40724DX T0C40725DX T0C40726DX T0C40727DX T0C40728DX T0C40729DX T0C40730DX T0C40731DX T0C40732DX T0C40733DX T0C40734DX T0C40735DX T0C40736DX T0C40737DX T0C40738DX T0C40739DX T0C40740DX T0C40741DX T0C40742DX T0C40743DX T0C40744DX T0C40745DX T0C40748DX T0C40749DX T0C40751DX T0C40806DX T0C40807DX T0C40808DX T0C40809DX T0C40810DX T0C40811DX T0C40812DX T0C40813DX T0C40814DX T0C40815DX T0C40816DX T0C40817DX T0C40818DX T0C40819DX T0C40820DX T0C40821DX T0C40822DX T0C40823DX T0C40824DX T0C40825DX T0C40827DX T0C40830DX T0C40832DX T0C40833DX T0C40834DX T0C40836DX T0C40837DX T0C40838DX T0C40839DX T0C40841DX T0C40842DX T0C40843DX T0C40844DX T0C40845DX T0C40846DX T0C40847DX T0C40848DX T0C40849DX T0C40850DX T0C40851DX T0C40852DX T0C40854DX T0C40855DX T0C40857DX T0C40858DX T0C40860DX T0K45413DX T0K45414DX T0K45415DX T0K45416DX T0K45418DX T0K45419DX T0K45422DX T0K45423DX T0K45424DX T0K45425DX T0K45426DX T0K45427DX T0K45428DX T0K45432DX T0K45443DX T0K45445DX T0K45450DX T0K45451DX T0K45456DX T0K45457DX T0K45458DX T0K45459DX T0K45463DX T0K45523DX T0L46116DX T0L46117DX T0L46133DX T0L46135DX T0L46139DX T0L46145DX T0L46147DX T0L46149DX T0L46393DX T0L46395DX T0L46396DX T0L46397DX T0L46398DX T0L46399DX T0L46400DX T0L46401DX T0L46402DX T0L46403DX T0L46404DX T0L46406DX T0L46410DX 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T1F49918DX T1F49919DX T1F49920DX T1F49921DX T1F49922DX T1F49923DX T1F49924DX T1F49925DX T1H50392DX T1H50393DX T1H50394DX T1H50395DX T1H50396DX T1H50398DX T1H50399DX T1H50400DX T1H50401DX T1H50402DX T1H50403DX T1H50404DX T1H50405DX T1H50406DX T1H50407DX T1I50635DX T1I50636DX T1I50637DX T1I50638DX T1I50639DX T1I50640DX T1I50641DX T1I50642DX T1I50643DX T1I50644DX T1J51082DX T1J51083DX T1J51086DX T1J51088DX T1J51089DX T1J51090DX T1J51091DX T1J51093DX T1J51094DX T1J51095DX T1J51096DX T1J51097DX T1J51099DX T1J51100DX T1J51101DX T1J51102DX T1J51103DX T1J51104DX T1J51105DX T1J51106DX T1J51107DX T1J51108DX T1J51109DX T1J51110DX T1J51111DX T1J51112DX T1J51114DX T1J51115DX T1J51241DX T1J51242DX T1J51243DX T1J51244DX T1J51246DX T1J51247DX T1J51248DX T1J51249DX T1J51250DX T1J51251DX T1J51252DX T1J51253DX T1J51254DX T1J51255DX T1J51256DX T1J51257DX T1J51258DX T1J51259DX T1J51261DX T1J51262DX T1J51263DX T1J51264DX T1J51265DX T1J51266DX T1J51267DX T1J51268DX T1J51269DX T1J51270DX T1J51271DX T1J51272DX T1J51273DX T1J51274DX T1J51275DX T1J51276DX T1J51277DX T1J51278DX T1J51279DX T1J51280DX T1J51281DX T1J51282DX T1J51284DX T1J51285DX T1J51286DX T1J51287DX T1J51371DX T1L52642DX T1L52643DX T1L52644DX T1L52645DX T1L52646DX T1L52647DX T1L52648DX T1L52649DX T1L52650DX T1L52651DX T1L52652DX T1L52653DX T1L52654DX T1L52655DX T1L52656DX T1L52657DX T1L52658DX T1L52660DX T1L52661DX T1L52662DX T1L52663DX T1L52664DX T1L52665DX T1L52666DX T1L52667DX T1L52668DX T1L52669DX T1L52670DX T1L52671DX T1L52862DX T2A52936DX T2A52937DX T2A52938DX T2A52939DX T2A52940DX T2A52941DX T2A52942DX T2A52943DX T2A52944DX T2A52945DX T2A52946DX T2A52947DX T2A52948DX T2A52949DX T2A52950DX T2A52951DX T2A52952DX T2A52953DX T2A52954DX T2A52955DX T2A52956DX T2A52957DX T2A52958DX T2A52959DX T2A52960DX T2A52961DX T2A52962DX T2A52963DX T2A52964DX T2A52965DX T2A52966DX T2A52967DX T2A52968DX T2A52969DX T2A52970DX T2A52971DX T2A52972DX T2A52973DX T2A52974DX T2A52976DX T2A52977DX T2A52979DX T2A52980DX T2A52981DX T2A52982DX T2A52983DX T2A52984DX T2A52985DX T2A52986DX T2A52988DX T2A52989DX T2A52990DX T2A52992DX T2A53154DX T2A53155DX T2D54671DX T2D54673DX T2D54674DX T2D54675DX T2D54676DX T2D54677DX T2D54678DX T2D54679DX T2D54680DX T2D54681DX T2D54682DX T2D54683DX T2D54684DX T2D54685DX T2D54686DX T2D54687DX T2D54688DX T2D54689DX T2D54690DX T2D54691DX T2D54692DX T2D54693DX T2D54694DX T2D54695DX T2D54696DX T2D54698DX T2D54699DX T2D54700DX T2D54701DX T2D54702DX T2D54703DX T2D54704DX T2D54705DX T2D54706DX T2D54707DX T2D54708DX T2D54709DX T2D54710DX T2D54711DX T2D54712DX T2D54713DX T2D54714DX T2D54715DX T2D54716DX T2D54717DX T2D54718DX T2D54719DX T2D54720DX T2D54721DX T2D54722DX T2D54723DX T2D54724DX T2D54725DX T2D54726DX T2D54728DX T2G55681DX T2G55682DX T2G55683DX T2G55684DX T2G55685DX T2G55686DX T2G55687DX T2G55688DX T2G55689DX T2G55690DX T2G55691DX T2G55692DX T2G55693DX T2G55694DX T2G55695DX T2G55696DX T2G55697DX T2G55698DX T2G55699DX T2G55700DX T2G55701DX T2G55702DX T2G55703DX T2G55704DX T2G55705DX T2G55706DX T2G55707DX T2G55708DX T2G55709DX T2G55710DX T2G55711DX T2G55712DX T2G55713DX T2G55714DX T2G55715DX T2G55716DX T2G55717DX T2G55718DX T2G55719DX T2G55720DX T2G55875DX T2G55876DX T2G55878DX T2G55879DX T2G55880DX T2G55881DX T2G55882DX T2G55883DX T2G55884DX T2H55941DX T2H55942DX T2H55945DX T2H55946DX T2H55949DX T2H55950DX T2H55952DX T2H55953DX T2H55954DX T2H55957DX T2H55960DX T2H55961DX T2H55962DX T2H55963DX T2H55964DX T2H55965DX T2H55966DX T2H55967DX T2H55969DX T2H55971DX T2H55972DX T2H55973DX T2H55974DX T2H55976DX T2H55977DX T2H55978DX T2H55979DX T2H55980DX T2H55981DX T2H55982DX T2H55984DX T2H55985DX T2H55986DX T2H55987DX T2H56126DX T2H56149DX T2H56151DX T2I56755DX T2I56756DX T2I56757DX T2I56758DX T2I56759DX T2I56760DX T2I56761DX T2I56762DX T2J57723DX T2J57724DX T2J57725DX T2J57728DX T2J57730DX T2J57731DX T2J57735DX T2J57738DX T2J57739DX T2J57740DX T2J57741DX T2J57742DX T2J57743DX T2J57744DX T2J57746DX T2J57747DX T2J57748DX T2J57749DX T2J57750DX T2J58016DX T2J58017DX T2J58018DX T2J58019DX T2J58020DX 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T9A29791DX T9A29793DX T9A29794DX T9A29797DX T9A29798DX T9A29799DX T9A29800DX T9A29801DX T9A29803DX T9A29807DX T9A29808DX T9A29809DX T9A29811DX T9A29812DX T9A29815DX T9A29825DX T9A29833DX T9A29834DX T9A29835DX T9A29837DX T9A29838DX T9A29853DX T9A29854DX T9A29855DX T9A29856DX T9A29858DX T9A29859DX T9A29861DX T9A29862DX T9A29930DX T9A29931DX T9A29933DX T9A29934DX T9A29935DX T9A29936DX T9A29937DX T9A29938DX T9A29939DX T9A29940DX T9A29941DX T9A29942DX T9A29943DX T9A29944DX T9A29945DX T9A29947DX T9A29948DX T9A29949DX T9A29950DX T9A29951DX T9B29974DX T9B30019DX T9B30098DX T9B30101DX T9B30103DX T9B30104DX T9B30105DX T9B30106DX T9B30107DX T9B30108DX T9B30109DX T9B30110DX T9B30111DX T9B30112DX T9B30115DX T9B30116DX T9B30132DX T9B30134DX T9B30239DX T9B30241DX T9B30244DX T9B30245DX T9B30246DX T9B30248DX T9B30249DX T9B30250DX T9B30251DX T9B30252DX T9B30253DX T9B30254DX T9B30256DX T9B30322DX T9B30324DX T9B30325DX T9B30326DX T9B30329DX T9B30330DX T9B30335DX T9B30418DX T9B30419DX T9B30420DX T9B30421DX 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T9K37898DX T9K37900DX T9K37901DX T9K37909DX T9K37910DX T9K37923DX T9K37927DX T9K37928DX T9K37931DX T9K38019DX T9K38020DX T9K38031DX T9K38032DX T9K38080DX T9L38129DX T9L38130DX T9L38131DX T9L38132DX T9L38137DX T9L38138DX T9L38139DX T9L38140DX T9L38141DX T9L38142DX T9L38261DX T9L38263DX T9L38265DX T9L38267DX T9L38269DX T9L38271DX T9L38272DX T9L38273DX T9L38274DX T9L38275DX T9L38279DX T9L38280DX T9L38282DX T9L38295DX T9L38296DX T9L38297DX T9L38298DX T9L38299DX T9L38304DX T9L38305DX T9L38308DX T9L38309DX T9L38321DX T9L38334DX T9L38449DX T9L38454DX T9L38455DX T9L38456DX T9L38457DX T9L38458DX T9L38473DX T9L38475DX T9L38477DX T9L38483DX T9L38488DX T9L38489DX T9L38490DX T9L38491DX T9L38493DX T9L38496DX T9L38498DX T9L38499DX T9L38500DX T9L38501DX T9L38502DX T9L38503DX T0C40420DX T0C40422DX T0C40723DX T0C40746DX T0C40747DX T0C40750DX T0L46426DX T1J51084DX T1J51092DX T1J51098DX T2D54672DX T2L59065DX T2L59071DX T3A59554DX T3A59624DX T3A59625DX T3A59627DX T3A59710DX T3A59712DX T3A59718DX T3A59720DX T3A59721DX T3A59723DX T3A59724DX T3A59725DX T3A59739DX T3A59740DX T3A59741DX T3A59742DX T3B60104DX T3B60155DX T3B60160DX T3B60161DX T3B60228DX T3B60229DX T3B60230DX T3B60256DX T3E63300DX T3E63304DX T3E63305DX T3E63306DX T3E63312DX T3E63313DX T3E63340DX T3E63342DX T3E63345DX T3E63349DX T3E63351DX T3E63353DX T3E63355DX T3E63357DX T3E63359DX T3E63361DX T3E63367DX T3E63517DX T3E63519DX T3E63572DX T3G66651DX T3G66652DX T3G66653DX T3G66655DX T3G66657DX T3G66658DX T3G67249DX T3G67250DX *T2G55721DX *T2G55722DX *T2J57745DX *T2J58040DX *T3A59722DX *T2L59062DX *T2K58541DX *T8J27714DX *T0C40400DX *T3F64327DX *T3G66660DX 対象数量 ： *3,510台 出荷時期 ： 平成28年4月‐*令和6年2月
製造販売業者等名称
製造販売業者の名称 ： コヴィディエンジャパン株式会社 製造販売業者の所在地： 東京都港区港南1丁目2番70号 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： 13B1X00069 外国製造業者名：Covidien
改修理由
海外製造元の調査により、ソフトウェアバージョン4.0.1、4.0.2、4.0.3を実装しているValleylab FT10 エネル ギープラットフォーム(以下、VLFT10)において、LigaSureベッセルシーリングシステムデバイス(以下LigaSure ハンドピース)を接続した際に、LigaSureハンドピースが未使用にも関わらず、使用済と誤認し、エラー「E420 使用が制限されています」または「E416ハンドピースが認識できません」を表示する場合があることが判明し ました。 2023年11月時点で、国内外において当該事象の報告を138件受領しており、これらはVLFT10のソフトウェアを 4.0.4にバージョンアップすることで解消されることから、自主改修を実施することと致しました。
危惧される具体的な健康被害
当該事象はLigaSureハンドピースを当該機器に接続した際に発生し、使用を制限するものであり、患者様への 使用前に気づくことができます。 当該事象が発生した場合の有害事象として、手技の遅延が危惧されますが、医療従事者が代替機への交換等の 適切な処置を取り得ることから重篤な健康被害には至らないものと考えられます。 これまでに国内外において当該自主改修の内容に関連する健康被害の報告は受領しておりません。
改修開始年月日
令和5年11月21日 情報提供の開始
効能・効果又は用途等
ジェネレータは、電気手術器用アクセサリと接続し、高周波電流を用いて以下のことを行う電気手術器である。 ・組織の切開・凝固 ・電解質溶液中でのバイポーラ切開・凝固 ・血管、組織束及びリンパ管のシーリング シーリング機器は、ジェネレータと接続し、血管、組織束及びリンパ管の結紮・切離を行う。
その他
当該製品の納入先はすべて把握しておりますので、該当する代理店及び医療機関に対して情報提供の上、改修を 実施致します。
担当者及び連絡先
担当者 ： 半沢 萌子 コヴィディエンジャパン株式会社 品質・市販後安全管理 電話番号： 03-6776-0009 FAX番号 ： 03-6774-4680