BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    MDR report key: 3113454 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02338
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 23, 2013
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED. WE DID NOT RECEIVE A BATCH NUMBER OR LOT NUMBER SO THEREFORE WE WERE UNABLE TO REVIEW THE MANUFACTURING RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CLIPS WERE NOT FORMING; THEY WERE MALFORMED. SECOND DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214634 LIGACLIP** ENDOSCOPIC CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1