BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7087580 · Received December 6, 2017

    Report

    Report Number
    1219930-2017-09491
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    May 13, 2017
    Report Date
    June 6, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    30884523003219
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE RELOAD WAS PRE-FIRED AND ENGAGED IN INTERLOCK. THERE WERE STAPLES PROTRUDING FROM THE PROXIMAL STAPLE CARTRIDGE CHANNEL. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MANUFACTURERS¿ QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. REPLICATION OF THE PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE INSTRUMENT FIRING BUTTON HAD BEEN PARTIALLY COMPRESSED AND RELEASED. IN THIS SITUATION, THE SAFETY INTERLOCK FEATURE WILL ENGAGE AND PREVENT THE RELOAD FROM FIRING A SECOND TIME BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION, AND PREVENT PATIENT HARM. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING GASTRIC SLEEVE THE STAPLER DID NOT FIRE THE CARTRIDGE, IT WAS READY TO FIRE BUT THE KNIFE DID NOT GO FORWARD AND THE LED LIGHT FROM THE CARTRIDGE WAS FLASHING. THE PATIENT IS ALIVE AND HAS NO INJURY. REPLACED BY NEW CARTRIDGE/LOAD TO COMPLETE THE CASE. THE DEVICE IS EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869016 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N6F0385KX 30884523003219

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR