Events

Rappel de Device Recall Fuse 1C Colonoscope

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par EndoChoice, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73067
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0694-2016
  • Date de mise en oeuvre de l'événement
    2015-12-18
  • Date de publication de l'événement
    2016-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142958
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Colonoscope and accessories, flexible/rigid - Product Code FDF
  • Cause
    The bending section of the device may partially separate from the insertion tube. potential for tissue trauma.
  • Action
    Consignees were notified on12/09/2015 that a sales representative would be contacting them to facilitate the exchange of the colonsocope and the defective device will be returned to EndoChoice.

Device

Device Recall Fuse 1C Colonoscope
  • Modèle / numéro de série
    Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS, F1C0219FUSE1CS, F1C0220FUSE1CS, F1C0221FUSE1CS, F1C0222FUSE1CS, F1C0223FUSE1CS, F1C0224FUSE1CS, F1C0225FUSE1CS, F1C0228FUSE1CS, F1C0229FUSE1CS, F1C0230FUSE1CS, F1C0231FUSE1CS, F1C0232FUSE1CS, F1C0233FUSE1CS, F1C0235FUSE1CS, F1C0236FUSE1CS, F1C0237FUSE1CS, F1C0238FUSE1CS, F1C0239FUSE1CS, F1C0241FUSE1CS, F1C0243FUSE1CS, F1C0245FUSE1CS, F1C0246FUSE1CS, F1C0247FUSE1CS, F1C0248FUSE1CS, F1C0249FUSE1CS, F1C0250FUSE1CS, F1C0251FUSE1CS, F1C0252FUSE1CS, F1C0253FUSE1CS, F1C0254FUSE1CS, F1C0255FUSE1CS, F1C0256FUSE1CS, F1C0257FUSE1CS, F1C0258FUSE1CS, F1C0259FUSE1CS, F1C0261FUSE1CS, F1C0262FUSE1CS, F1C0263FUSE1CS, F1C0264FUSE1CS, F1C0266FUSE1CS, F1C0267FUSE1CS, F1C0268FUSE1CS, F1C0269FUSE1CS, F1C0270FUSE1CS, F1C0271FUSE1CS, F1C0272FUSE1CS, F1C0273FUSE1CS, F1C0274FUSE1CS, F1C0276FUSE1CS, F1C0277FUSE1CS, F1C0278FUSE1CS, F1C0279FUSE1CS, F1C0280FUSE1CS, F1C0281FUSE1CS, F1C0282FUSE1CS, F1C0284FUSE1CS,  F1C0285FUSE1CS, F1C0287FUSE1CS, F1C0288FUSE1CS, F1C0289FUSE1CS, F1C0290FUSE1CS, F1C0291FUSE1CS, F1C0292FUSE1CS, F1C0293FUSE1CS, F1C0294FUSE1CS, F1C0296FUSE1CS, F1C0297FUSE1CS, F1C0298FUSE1CS, F1C0299FUSE1CS, F1C0300FUSE1CS, F1C0301FUSE1CS, F1C0305FUSE1CS ; Item number: FSC-330-C6333, Model number: C38s-150, Serial numbers: 0600200, 0600201, 0600202, 0600203, 0600204, 0600205 and 0600206; Item number: FSC-3300-ST, Model number: F1C, Serial numbers: F1C0214FUSE1C-150F1C0241FUSEC1, F1C0244FUSE1C-A, F1C0244FUSEC1, F1C0255FUSE1C-A, F1C0259FUSE1C, F1C0271FUSE1C, F1C0283FUSE1C, F1C0312FUSE1C, F1C0313FUSE1C, F1C0322FUSE1C, F1C0334FUSE1C, F1C0356FUSE1C, F1C0382FUSE1C, F1C0388FUSE1C, F1C0425FUSE1C, F1C0433FUSE1C, F1C0437FUSE1C, F1C0447FUSE1C, F1C0449FUSE1C, F1C0458FUSE1C, F1C0461FUSE1C, F1C0475FUSE1C, F1C0479FUSE1C, F1C0484FUSE1C, F1C0488FUSE1C, F1C0489FUSE1C, F1C0516FUSE1C, F1C0526FUSE1C, F1C0530FUSE1C, F1C0531FUSE1C, F1C0536FUSE1C, F1C0537FUSE1C, F1C0540FUSE1C, F1C0542FUSE1C, F1C0543FUSE1C, F1C0544FUSE1C, F1C0545FUSE1C, F1C0546FUSE1C, F1C0547FUSE1C, F1C0549FUSE1C, F1C0584FUSE1C, F1C0586FUSE1C, F1C0603FUSE1C, F1C0640FUSE1C, F1C0660FUSE1C, F1C0668FUSE1C, F1C0691FUSE1C, F1C0692FUSE1C, F1C0693FUSE1C, F1C0694FUSE1C, F1C0709FUSE1C, F1C0714FUSE1C, F1C0736FUSE1C, F1C0739FUSE1C, F1C0742FUSE1C, F1C0745FUSE1C, F1C0749FUSE1C, F1C0758FUSE1C, F1C0763FUSE1C, F1C0765FUSE1C, F1C0767FUSE1C, F1C0776FUSE1C, F1C0778FUSE1C, F1C0779FUSE1C, F1C0786FUSE1C, F1C0790FUSE1CL, F1C0791FUSE1CL, F1C0794FUSE1C, F1C0796FUSE1C, F1C0799FUSE1C, F1C0800FUSE1CL, F1C0802FUSE1C, F1C0806FUSE1C, F1C0811FUSE1C, F1C0812FUSE1C, F1C0814FUSE1C, F1C0817FUSE1C, F1C0818FUSE1C, F1C0825FUSE1C, F1C0827FUSE1C, F1C0828FUSE1C, F1C0829FUSE1C, F1C0831FUSE1C, F1C0833FUSE1C, F1C0834FUSE1C, F1C0835FUSE1C, F1C0837FUSE1C, F1C0838FUSE1C, F1C0841FUSE1C, F1C0849FUSE1C, F1C0852FUSE1C, F1C0857FUSE1C, F1C0858FUSE1C, F1C0859FUSE1C, F1C0860FUSE1C, F1C0862FUSE1C, F1C0863FUSE1C, F1C0864FUSE1C, F1C0866FUSE1C, F1C0867FUSE1C, F1C0868FUSE1C, F1C0870FUSE1C, F1C0871FUSE1C, F1C0872FUSE1C, F1C0873FUSE1C, F1C0874FUSE1C, F1C0875FUSE1C, F1C0876FUSE1C, F1C0878FUSE1C, F1C0879FUSE1C, F1C0880FUSE1C, F1C0883FUSE1C, F1C0884FUSE1C, F1C0885FUSE1C, F1C0893FUSE1C, F1C0894FUSE1C, F1C0895FUSE1C, F1C0898FUSE1C, F1C0900FUSE1C, F1C0902FUSE1C, F1C0905FUSE1C, F1C0906FUSE1C, F1C0907FUSE1C, F1C0908FUSE1C, F1C0910FUSE1C F1C0921FUSE1C; Item number: FSC330-A6334, Model number: F1C-MC90, Serial numbers: 0700200, 0700204, 0700205, 0700207, 0700209, 0700210, 0700212, 0700215 and 0700217; Item number: FDC-3300-133, Model number: Fuse Colo 133, Serial numbers: F1C0201FUSE1C-133, F1C0202FUSE1C-133, F1C0203FUSE1C-133, F1C0204FUSE-133, F1C0205FUSE1C-133, F1C0206FUSE1C-133, F1C0207FUSE1C-133, F1C0208FUSE1C-133, F1C0209FUSE1C-133, F1C0210FUSE1C-133, F1C0211FUSE1C-133, F1C0216FUSE1C-133, F1C0217FUSE1C-133, F1C0218FUSE1C-133, F1C0219FUSE1C-133, F1C0221FUSE1C-133, F1C0222FUSE1C-133, F1C0223FUSE1C-133, F1C0224FUSE1C-133. F1C0225FUSE1C-133, F1C0226FUSE1C-133, F1C0227FUSE1C-133, F1C0228FUSE1C-133, F1C0229FUSE1C-133, F1C0230FUSE1C-133, F1C0235FUSE1C-133 and Item number: FSC-3300-150, Model number: Fuse Colo 150, Serial numbers: F1C0202FUSE1C-150, F1C0203FUSE1C-150, F1C0204FUSE1C-150, F1C0205FUSE1C-150, F1C0206FUSE1C-150, F1C0207FUSE1C-150, F1C0208FUSE1C-150, F1C0209FUSE1C-150, F1C0210FUSE1C-150, F1C0211FUSE1C-150, F1C0212FUSE1C-150, F1C0214FUSE1C-150.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Colombia, Denmark, France, Germany, Indonesia, Israel, Italy, Japan, Malaysia, Republic of Korea, Spain and Switzerland.
  • Description du dispositif
    Fuse 1C Colonoscope
  • Manufacturer
    EndoChoice, Inc.

Manufacturer

EndoChoice, Inc.
  • Adresse du fabricant
    EndoChoice, Inc., 11810 Wills Rd Ste 100, ATTN: Theron Gober, Alpharetta GA 30009-2081
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA