BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP APPLIER

    MDR report key: 10384514 · Received August 7, 2020

    Report

    Report Number
    MW5095966
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    July 13, 2020
    Report Date
    August 6, 2020
    Manufacturer
    COVIDIEN/MEDTRONIC / COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC CLIP APPLIERS, RELOADS, STAPLERS AND ENDO GIA HAVE BEEN DELIVERED WITH FOD. THE FOD APPEARS TO BE METAL SHAVINGS, BLACK PARTICLES, AND FUZZ IN THE STERILE PACKAGING. (B)(6) HEALTHCARE HAS FOUND THESE ISSUES AT RECEIVING PRIOR TO DELIVERY TO THE OPERATING ROOM. WE HAVE NOTIFIED MEDTRONIC OF OVER 50-75 INSTANCE ALONG WITH PICTURE AND PRODUCT. MEDTRONIC HAS YET TO PROVIDE QUALITY ASSESSMENT TO THE FINDING. WE DO NOT FEEL AS THOUGH THIS IS BEING TAKEN SERIOUSLY AS THE EVENTS DID NOT TOUCH A PATIENT OR IMPACT THE OPERATING ROOM. IF THESE ITEMS WERE NOT CAUGHT PRIOR TO SURGERY, THERE WOULD HAVE BEEN A POTENTIAL ADVERSE AFFECT/IMPACT TO THE PATIENT AND / OR STAFF. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846850 ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP COVIDIEN/MEDTRONIC / COVIDIEN
    846851 ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP COVIDIEN/MEDTRONIC / COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other