BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP, IMPLANTABLE

    MDR report key: 8009110 · Received October 26, 2018

    Report

    Report Number
    9612501-2018-01882
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Report Date
    October 26, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER E1999001. BRAND NAME: ENDO CLIP, ENDO CLIP II, ENDO CLIP III, PREMIUM SURGICLIP. MANUFACTURER NAME, CITY AND STATE: COVIDIEN LP (B)(4). DEVICE IDENTIFICATION: (B)(4). OF THE 9 EVENTS BEING REPORTED, 4 EVENTS WERE DETERMINED TO BE THE RESULT OF MISAPPLICATION BY THE USER, 4 EVENTS HAD NO DEVICE FAILURE, AND 1 EVENT WERE DETERMINED TO THE RESULT OF A ASSEMBLY OR COMPONENT ERROR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <(><<)>NOE> 9 <(><<)>/NOE> MALFUNCTION EVENTS REPORTED BETWEEN JULY 1, 2018 AND SEPTEMBER 30, 2018. 5 EVENTS ASSOCIATED WITH DEVICE MECHANICAL FUNCTIONING OF MACHINERY, MOVING PARTS OR TOOLS OF THE DEVICE BEING CHANGED OR MODIFIED. 3 EVENTS ASSOCIATED WITH ANY DEVIATIONS FROM DEVICE DOCUMENTED PERFORMANCE SPECIFICATIONS RELATING TO MECHANICAL DEFECTS, INCLUDING MOVING PARTS OR SUBASSEMBLIES, ETC. 1 EVENT ASSOCIATED WITH UNDESIRED DAMAGE OR BREAKAGE OF THOSE MATERIALS USED IN DEVICE CONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849514 CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1