BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 7719026 · Received July 25, 2018

    Report

    Report Number
    9612501-2018-01356
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Report Date
    October 3, 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. 3 DEVICES EVALUATED. PATIENT CODES: 2692 DEVICE CODES: 2976, 2984 RESULT CODES: 213, 3243, 110 CONCLUSION CODES: 67, 61, 23. OF THE 3 EVENTS BEING REPORTED, 1 EVENT WAS DETERMINED TO BE THE RESULT OF MISAPPLICATION BY THE USER, 1 EVENT HAD NO DEVICE FAILURE, AND 1 EVENT WAS DETERMINED TO BE THE RESULT OF A COMPONENT ERROR. 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

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS REPORTED BETWEEN APRIL 1, 2018 AND JUNE 30, 2018. 1 EVENT ASSOCIATED WITH AN UNDESIRED MATERIAL CHANGE IN SHAPE OR PROPERTY CAUSED BY EXTERNAL FORCES. 1 EVENT ASSOCIATED WITH DEVICE MECHANICAL FUNCTIONING OF MACHINERY, MOVING PARTS OR TOOLS OF THE DEVICE BEING CHANGED OR MODIFIED. 1 EVENT ASSOCIATED WITH ANY UNINTENDED SOUND WHICH EMANATES FROM A DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563221 ENDO CLIP III CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176630B

    Patients

    Seq Age Sex Outcome Treatment
    1