BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1821117 · Received August 10, 2007

    Report

    Report Number
    1527736-2007-05302
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 12, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS FOUND THAT INSTRUMENTS A AND B WERE RETURNED WITH THE JAWS OVER TWISTED. THE INSTRUMENTS WERE CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE CONDITION OF THE JAWS. THE INSTRUMENTS LOCKED OUT AS INTENDED. INSTRUMENT C WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT AS INTENDED. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE FINDINGS. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY, DEFECTIVE CLIP. 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 20 LARGE TITANIUM LIGATING CL FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA C4FT87

    Patients

    Seq Age Sex Outcome Treatment
    1