BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP*MCA

    MDR report key: 1872617 · Received October 18, 2010

    Report

    Report Number
    3005075853-2010-05904
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE COVER OUT OF POSITION THE ANALYSIS RESULTS OF DEVICE (A) FOUND THAT IT WAS RECEIVED WITH THE CARTRIDGE COVER OUT OF ITS INTENDED POSITION. FURTHER EVALUATION FOUND THAT IT WAS EMPTY AND LOCKED OUT. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT FOUND CONDITION OF THE CARTRIDGE COVER MAY LEAD DROPPING OR EJECTED CLIPS. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS RESULTS OF DEVICE (B) FOUND THAT IT WAS RECEIVED EMPTY AND WITH THE OUTER WRAP DAMAGED CAUSING THAT THE CARTRIDGE COVER LOSES ITS INTENDED POSITION. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH # G9K570 MFG DATE 05/20/2010; EXP DATE: 04/20/2015. CARTRIDGE COVER. THE ANALYSIS RESULTS FOUND THAT DEVICE (C) 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. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. BATCH # G9KM7U MFG DATE: 08/05/2010; EXP DATE 07/05/2015.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THE DEVICES WERE FIRING CLIPS THAT WERE NOT FULLY FORMED. THEY FELL OFF THE TISSUE AFTER THEY WERE FIRED. ONE OF THEM WAS DROPPING CLIPS OUT OF THE JAWS PRIOR TO IT BEING FIRED. THE PROCEDURE WAS COMPLETED WITH NEW DEVICES. THERE WAS NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SUDDEN PERFORMANCE DECREMENT THEN TELEMETRY COULD NOT BE ESTABLISHED. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED (B)(6), 2010, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP*MCA CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1