BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ENDO CLIP

    MDR report key: 8275763 · Received January 24, 2019

    Report

    Report Number
    9612501-2019-00149
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    January 24, 2019
    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, PREMIUM SURGICLIP. MANUFACTURER NAME, CITY AND STATE: US SURGICAL (B)(4). DEVICE IDENTIFICATION: 176625, 176615, 134044. 3 DEVICES EVALUATED. PATIENT CODES: 2692 DEVICE CODES: 2984, 1384, 2921 RESULT CODE: 213, 3243 CONCLUSION CODE: 67, 61. 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 COULD NOT BE CONFIRMED. 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 OCTOBER 1, 2018 AND DECEMBER 31, 2018. 1 EVENT ASSOCIATED WITH DEVICE MECHANICAL FUNCTIONING OF MACHINERY, MOVING PARTS OR TOOLS OF THE DEVICE BEING CHANGED OR MODIFIED. 1 EVENT ASSOCIATED WITH THE USE OF THE DEVICE IN TERMS OF USER EXPERIENCING DIFFICULTY OPENING AND CLOSING THE DEVICE, EVEN IF THE OPERATION IS BEING PERFORMED ACCORDING TO LABELED INSTRUCTIONS FOR USE. 1 EVENT ASSOCIATED WITH MECHANICAL ACTIONS OR DEFECTS, INCLUDING MOVING PARTS OR SUBASSEMBLIES, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67865 ENDO CLIP CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1