BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1844892 · Received September 27, 2010

    Report

    Report Number
    3005075853-2010-05499
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). FEEDER SHOE. DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS FUNCTIONALLY TESTED TO EVALUATE ANY OPENING ISSUES. UPON FUNCTIONAL TESTING OF THE DEVICE, NO CLIPS WERE FED INTO THE JAWS. IN ORDER TO EVALUATE THE DEVICE¿S INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING OF THE DEVICE, THE FEEDER SHOE WAS FOUND TO BE DAMAGED IN THE TAB THAT INTERACTS WITH THE FEED BAR, LEADING TO THE FOUND FEEDING ISSUES. 14 CLIPS WERE FOUND ON THE CLIP TRACK. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. NO TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED OPENING ISSUES. DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. NO OPENING ISSUES WERE NOTED DURING TESTING. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT THE 11TH FIRING SEQUENCE; THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE SURGEON FIRED THE FIRST DEVICE, THE JAWS WOULD NOT OPEN AND LOCKED OUT. HE MANUALLY PRIED THE DEVICE OPEN AND USED A SECOND LIKE DEVICE; THIS OCCURRED AGAIN AND THE DEVICE WAS REMOVED IN THE SAME FASHION. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4T06R

    Patients

    Seq Age Sex Outcome Treatment
    1