BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 4090154 · Received September 15, 2014

    Report

    Report Number
    3005075853-2014-06419
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 2, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: HOW DID DEVICE MISFEED? DID CLIPS FEED SIDEWAYS? DID CLIPS PARTIALLY FEED OR NOT FEED AT ALL? DID MULTIPLE CLIPS FEED? DID CLIPS SLOW FEED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS FROM THE CLIP APPLIER WERE CROSSING AND MISFEEDING. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS COMPLETED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569039 ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1