BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 3863821 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03886
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE DURING FIRING THE CLIPS THE SURGEON STATED THEY WERE MALFORMED. THIS INFORMATION WAS ON A NOTE WITH THE DEVICE IN A BAG LEFT IN THE MATERIALS DEPARTMENT. THERE WERE NO OR CONTACTS OR SURGEONS NAME PROVIDED. THERE WILL BE NO OTHER INFORMATION PROVIDED FROM THIS ACCOUNT FOR THE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341059 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1