BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING C

    MDR report key: 1112586 · Received August 11, 2008

    Report

    Report Number
    3005075853-2008-01085
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 2008
    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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 08/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, WHEN THE NURSE WAS FIRING THE DEVICE TO LOAD IT, THE CLIP FELL OUT. THE SURGEON THEN TRIED TO FIRE IT, BUT THE CLIP WOULD NOT CLOSE AND FELL OUT IN THE OPEN POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING C FZP ETHICON ENDO-SURGERY, LLC NA D4HK66

    Patients

    Seq Age Sex Outcome Treatment
    1