BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIX UNIVERSAL CLIP APPLIER

    MDR report key: 3113215 · Received May 8, 2013

    Report

    Report Number
    2027111-2013-00163
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 6, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT NUMBER IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE - "CLIP APPLIER WAS STICKING. SURGEON HAD TO PUSH THE HANDLE FORWARD AFTER EACH CLIP WAS FIRED TO OPEN JAWS AND RELEASED HANDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202403 EPIX UNIVERSAL CLIP APPLIER NONE FZP APPLIED MEDICAL CA500 1188204

    Patients

    Seq Age Sex Outcome Treatment
    1