BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRO-CLIP

    MDR report key: 9561921 · Received January 7, 2020

    Report

    Report Number
    1219930-2020-00221
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 27, 2019
    Report Date
    March 25, 2020
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    HBQ
    UDI-DI
    10884521057616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, H3, H6 H3 EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE PRODUCT NOTED THE INSTRUMENT WAS RECEIVED WITH THE HOOK TIP BROKEN AND MISSING. THE DAMAGED INSTRUMENT PRECLUDES A FUNCTIONAL EVALUATION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE DISENGAGED HOOK MAY OCCUR IF THE INSTRUMENT WAS MISHANDLED DURING APPLICATION. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. 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

    ACCORDING TO THE REPORTER, DURING THE DEMONSTRATION, THE TIP OF THE HOOK WAS FOUND TO BE CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24978 LAPRO-CLIP INSTRUMENT, CLIP REMOVAL HBQ COVIDIEN LP LLC NORTH HAVEN 8886848799 C5A3106 10884521057616

    Patients

    Seq Age Sex Outcome Treatment
    1