BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1318685 · Received February 23, 2009

    Report

    Report Number
    1527736-2008-01185
    Event Type
    Malfunction
    Date Received
    February 23, 2009
    Date of Event
    February 7, 2008
    Report Date
    February 8, 2008
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT D: NON CLEARING MISFIRE. EVAL SUMMARY: TWENTY THREE DEVICES WERE RETURNED FOR ANALYSIS. THE ANALYSIS RESULTS FOR THE ER420 INSTRUMENT (D) CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED, FED AND FORMED 10 CONFORMING CLIPS AND THEN A NON-CLEARING MISFIRE ISSUE WAS NOTED; AFTER CYCLING THE TRIGGER 8 TIMES THE INSTRUMENT FED AND FORMED THE REMAINING 11 CONFORMING CLIPS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FIRING ISSUE. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (I) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT AS INTENDED. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (Q) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LOCKED OUT AS INTENDED. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (V) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS. THE INSTRUMENT LCOKED OUT AS INTENDED. AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE FINDING FOR DEVICES I, Q AND V. THE ER420 INSTRUMENTS (A, B, C, E, F, G, H, J, K, L, M, N, O, P, R, S, T, U, W) WERE RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENTS WERE CYCLED, FED, AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING REQUIREMENTS WHEN TESTED. NO JAMMING ISSUES WERE NOTED DURING ANALYSIS. THE INSTRUMENTS WERE FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. WE HAVE DOCUMENTED AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS JAMMING ON UNK FIRINGS. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE CASE WITH NO PT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR ANALYSIS. THIS OCCURRED WITH FIVE DEVICES. THEY WANT THE REMAINING DEVICES WITH THE SAME LOT NUMBER TO BE ANALYZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL FZP FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA D4HT65

    Patients

    Seq Age Sex Outcome Treatment
    1