BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 8781830 · Received July 11, 2019

    Report

    Report Number
    1219930-2019-04093
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    April 25, 2019
    Report Date
    September 23, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 A LAPAROSCOPIC NEPHRECTOMY, THE STAPLER WOULD NOT FIRE. AT LEAST ONE CLIP WAS FIRED FROM THE DEVICE AND EITHER THAT CLIP OR ANY CLIPS AFTER WERE NOT LOADING PROPERLY INTO THE JAWS. A NEW STAPLER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574681 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR