Events

Rappel de Device Recall Pentax Video Duodenoscope

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 Pentax of America 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
    79237
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0643-2018
  • Date de mise en oeuvre de l'événement
    2018-02-13
  • Date de publication de l'événement
    2018-02-20
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161728
  • 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
    Duodenoscope and accessories, flexible/rigid - Product Code FDT
  • Cause
    The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the o-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the operation manual in order to mitigate the potential risk of infection in flexible endoscopy.
  • Action
    Pentax Medical sent an Urgent Medical Device Correction/Removal letter dated February 7, 2018, to the United States Customers. The consignee letter includes a customer response form and a revised operator manual with the added recommended periodic maintenance. The letter requests the return of the form which includes an accounting of the devices (by serial number) owned by the facility. The firm is to contact the consignee to arrange return of the affected units and to provide loaner devices as needed. For further questions, please call 1 (800) 431-5880 ext. 2064.

Device

Device Recall Pentax Video Duodenoscope
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
  • Description du dispositif
    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
  • Manufacturer
    Pentax of America Inc

Manufacturer

Pentax of America Inc
  • Adresse du fabricant
    Pentax of America Inc, 3 Paragon Dr, Montvale NJ 07645-1782
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    USFDA