BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1821135 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05274
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Report Date
    July 30, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    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 AN LAVH PROCEDURE THE DEVICE CLOSED ON THE TISSUE BUT WOULD NOT FIRE. THE DEVICE WOULD NOT OPEN CAUSING THE SURGEON TO USE CAUTERY SCISSORS TO CUT THE TISSUE AND THE DEVICE OUT. THE TISSUE WAS TRANSECTED AT THIS POINT, SO IT WAS NOT NECESSARY TO USE ANOTHER DEVICE. THE SURGEON FORCED THE JAWS OPEN AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA DH4JO3

    Patients

    Seq Age Sex Outcome Treatment
    1