BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1831412 · Received December 20, 2007

    Report

    Report Number
    1527736-2007-08693
    Event Type
    Malfunction
    Date Received
    December 20, 2007
    Date of Event
    December 12, 2007
    Report Date
    December 12, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE THE DEVICE THE CLIPS WOULD NOT FIRE AND THEN WHEN THEY TRIED TO FIRE AGAIN THE CLIPS FELL OUT. THEY RETRIEVED THE CLIPS MANUALLY AND THEN THE DEVICE STUCK ON THE TISSUE AND TORE THE CYSTIC DUCT. THEY MANIPULATED THE HANDLE AND IT RELEASED FROM THE TISSUE. THEY THEN USED A SECOND DEVICE AND IT WORKED FINE AND THEY WERE ABLE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. DEVICE IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4JE2H

    Patients

    Seq Age Sex Outcome Treatment
    1