BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1822208 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08189
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 9, 2007
    Report Date
    November 9, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS DID NOT CLOSE PROPERLY AND SLIPPED OFF THE DUCT. THE SECOND DEVICE WAS OPENED AND GAVE THE SAME RESULTS. GRASPER WAS USED TO CLOSE THE CLIPS TIGHTER TO BE HELD ON THE DUCT TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1