BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 3802361 · Received May 9, 2014

    Report

    Report Number
    3005075853-2014-03148
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 15, 2014
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, INCOMPLETE CLIP CLOSURE; CLIPS WERE MALFORMED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. NO DEVICE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281697 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA K4CF4M

    Patients

    Seq Age Sex Outcome Treatment
    1