BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5

    MDR report key: 1061940 · Received March 14, 2007

    Report

    Report Number
    1527736-2007-01669
    Event Type
    Malfunction
    Date Received
    March 14, 2007
    Report Date
    December 12, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (A) WAS REC'D IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND THE LOCKOUT WAS FIRED THROUGH. THE ANALYSIS RESULTS CONFIRMED THAT ONE EL5ML DEVICE (B) WAS REC'D IN GOOD VISUAL CONDITION. AFTER A SIMPLE ACTUATION OF THE FIRING TRIGGER, THE DEVICE RELEASED CONFORMING CLIPS WITHOUT ANY DIFFICULTIES. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, 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. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MFG PROCESS. INSTRUMENT A: EMPTY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CHOLECYSTECTOMY PROCEDURE THAT THE DEVICE DID NOT HAVE ALL THE CLIPS AND WHEN USED IT LOCKED. NO FURTHER INFO WAS PROVIDED. THERE WAS NO ADVERSE PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX 5 FZP FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA C4EX86

    Patients

    Seq Age Sex Outcome Treatment
    1 *