BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP

    MDR report key: 7514888 · Received May 15, 2018

    Report

    Report Number
    1219930-2018-02642
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    January 5, 2018
    Report Date
    October 5, 2018
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    FZP
    UDI-DI
    10884521057876
    PMA / PMN Number
    K954435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE PHOTO AND ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PHOTO DEPICTS WHAT APPEAR TO BE DARK SPOTS ON TISSUE. THE INSTRUMENT WAS RECEIVED PARTIALLY APPLIED WITH SIX REMAINING CLIPS. A SMALL AMOUNT OF LUBRICANT OBSERVED ON DISTAL JAW CAMS, THE AMOUNT WAS NOT DEEMED EXCESSIVE. THE INSTRUMENT WAS APPLIED TO APPROPRIATE TEST MEDIA FOR FUNCTIONAL EVALUATION. THE INSTRUMENT WAS FOUND TO CYCLE WITHOUT BINDING. CLIPS ADVANCED INTO THE JAWS, FORMED PROPERLY, AND WERE HELD SECURELY IN PLACE AFTER THE FULL FORMATION WAS ACHIEVED AND THE FIRING HANDLE WAS RELEASED. IN ADDITION, WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED TO PREVENT THE JEWS FROM APPROXIMATING. NO ABNORMALITIES WERE OBSERVED. RECORDS FOR EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. 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 ORCHIDOPEXY PROCEDURE, IN A FIRST STAGE OF STEPHEN-FOWLER PROCEDURE, THE COMPONENT OF THE CLIP APPLIER THAT APPEARED TO BE METAL DEBRIS FELL INTO THE PATIENT. THE DEBRIS WAS WASHED OUT USING SUCTION IRRIGATION. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358352 ENDO CLIP CLIP, IMPLANTABLE FZP COVIDIEN LP LLC NORTH HAVEN 176620 N6F0540CX 10884521057876

    Patients

    Seq Age Sex Outcome Treatment
    1