BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1850485 · Received October 1, 2010

    Report

    Report Number
    3005075853-2010-05639
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 8, 2010
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE DEVICE WAS GOING TO BE CLIPPED AT THE CYSTIC DUCT AFTER A FEW FIRINGS, THE CLIP WAS MALFORMED. THE DEVICE WAS FIRED WITHOUT CLAMPING THE TISSUE, BUT SCISSORING OCCURRED. THE DEVICE STOPPED BEING USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4RK4W

    Patients

    Seq Age Sex Outcome Treatment
    1