BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 8645600 · Received May 28, 2019

    Report

    Report Number
    1219930-2019-03109
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    March 18, 2019
    Report Date
    May 28, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATIC PROCEDURE, THE STAPLER DID NOT WORK. THE DEVICE WAS ABLE TO FIRE AT FIRST BUT PRESENTED A NOISE AND CRASHED THEN THE JAWS OF THE DEVICE LOCK ON THE FABRIC. SUBSTITUTING THE DEVICE WAS NECESSARY TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441280 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1