BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP** ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 1801470 · Received August 16, 2010

    Report

    Report Number
    3005075853-2010-04659
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SURGEON WAS APPLYING THE FOURTH CLIP ON THE TISSUE FOR ADDITIONAL SECURING WHEN A SECOND CLIP FELL UNFORMED INTO THE PATIENT. ATTEMPTED TO LOCATE THE CLIP, RETRIEVED BUT BEFORE REMOVAL THE CLIP WAS DROPPED AND IT COULD NOT BE LOCATED. NO X-RAY OR TESTING WAS USED TO LOCATE THE CLIP. THE CLIP WAS ABOVE THE LIVER BED WITH A LOT OF SURROUNDING TISSUE AND THE SURGEON FELT IT WAS NOT AN ISSUE. ANOTHER DEVICE WAS NOT REQUIRED FOR THE PROCEDURE AND THE CASE WAS COMPLETED AS NORMAL. THERE WAS NO ADVERSE CONSEQUENCE 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 F4P230

    Patients

    Seq Age Sex Outcome Treatment
    1