BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5

    MDR report key: 953272 · Received April 17, 2007

    Report

    Report Number
    1527736-2007-02803
    Event Type
    Malfunction
    Date Received
    April 17, 2007
    Date of Event
    December 14, 2006
    Report Date
    December 15, 2006
    Manufacturer
    ETHICON ENDO-SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT A: BROKEN ADVANCER INSTRUMENT B: BATCH#C9D084; EXP DATE:10/03/2011; MFR DATE 11/03/2006; MALFORMED CLIPS. INSTRUMENT C: BATCH #C9D13A; EXP DATE: 10/14/2011; MFR DATE 11/14/2006; JAW DISENGAGED FROM THE CAM, EMPTY INSTRUMENT. INSTRUMENT D: BATCH#C9D13A; EXP DATE: 10/14/2011; MFR DATE 11/14/2006; BROKEN CAM, DISENGAGED JAW. INSTRUMENT E: BATCH#C9D13A; EXP DATE: 10/14/2011; MFR DATE 11/14/2006; BROKEN ADVANCER. EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (A) WAS RECEIVED WITH THE ADVANCER BROKEN. THE INSTRUMENT WAS CYCLED, FED AND FORMED 4 PEAR SHAPED CLIPS DUE TO THE ADVANCER CONDITION THAT DID NOT ALLOW THE CLIP TO BE COMPLETELY FED INTO THE JAWS. THE EL5ML INSTRUMENT (B) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED AND FORMED 1 CLIP WITH GAP AND 1 PEAR SHAPED CLIP. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND FEEDING ISSUES. THE ANALYSIS RESULTS CONFIRMED THAT THE EL5ML DEVICE (C) WAS RECEIVED EMPTY AND WITH THE LOCKOUT FIRED THROUGH. THEREFORE, NO FUNCTIONAL TEST COULD BE PERFORMED. IN ADDITION, THE JAW RAMP WAS FOUND TO BE DISENGAGED FROM THE CAM. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (D) WAS RETURNED WITH THE CAM BROKEN AND THE JAW DISENGAGED FRONT THE CAM. THE DEVICE WAS CYCLED, AND EJECTED THE REMAINING CLIPS DUE TO THE CAM CONDITION. THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (E) WAS RECEIVED WITH TWO MALFORMED CLIPS INTO THE JAWS AND A BROKEN ADVANCER. THE INSTRUMENT WAS CYCLED AND MISFED THE CLIPS DUE TO THE ADVANCER CONDITION. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPROSCOPIC HERNIA PROCEDURE THE DEVICE MISFIRED. THE CASE WAS COMPLETED WITH A 6TH NEW LIKE DEVICE AFTER 5 DEVICES WERE TRIED TO COMPLETE THE CASE. NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5 FZP FZP ETHICON ENDO-SURGERY, INC (CINCINNATI) NA C4FM9W

    Patients

    Seq Age Sex Outcome Treatment
    1 *