BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7127531 · Received December 18, 2017

    Report

    Report Number
    1219930-2017-10116
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    November 21, 2017
    Report Date
    January 24, 2018
    Manufacturer
    COVIDIEN NORTH HAVEN - MFG
    Product Code
    GDW
    PMA / PMN Number
    K133938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. FUNCTIONAL TESTING OF THE RELOAD FOUND NO ABNORMALITIES. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE INSTRUMENT FIRING HANDLE HAD BEEN PARTIALLY COMPRESSED AND RELEASED AFTER PRESSING THE GREEN FIRING BUTTON. 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. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY 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: OCCURRED DURING A LAPAROSCOPIC SLEEVE PROCEDURE. ONCE INSERTED INSIDE THE TROCAR, THE JAWS OF THE DEVICE WOULD NOT OPEN. THIS ALSO CAUSED AN UNLOADING PROBLEM. THE CASE WAS COMPLETED USING A NEW RELOAD AND HANDLE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906480 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN NORTH HAVEN - MFG EGIATRS60AMT 7265034NH

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening