BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 2230371 · Received September 1, 2011

    Report

    Report Number
    3005075853-2011-03621
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MULTIPLE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURES THERE WERE MALFORMED PEAR SHAPED CLIPS OBSERVED DURING THE CASES FOR THE YEAR. THERE IS NO CONFIRMATION ON HOW MAY PROCEDURES, SPECIFIC DETAILS, EVENT DATES OR LOT OR BATCH NUMBERS FOR THE DEVICES INVOLVED IN THE CASES. ALL DEVICES WERE DISCARDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1