BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 3161419 · Received May 9, 2013

    Report

    Report Number
    3161419
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 9, 2013
    Manufacturer
    UNK
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING LAP GASTRIC BYPASS, A PIECE OF THE BOWEL GRASPER BROKE OFF WHILE INSIDE OF PT. THE PIECE WAS RETRIEVED BY ATTENDING SURGEON AND ACCOUNTED FOR IN ITS ENTIRETY. THE INSTRUMENT WAS REMOVED FROM THE FIELD. NO INJURY NOTED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAP GASTRIC BYPASS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205182 UNK BOWEL GRASPER GCJ UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *