BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1170291 · Received September 12, 2008

    Report

    Report Number
    3005075853-2008-01687
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 13, 2008
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JAW. EVALUATION SUMMARY. THE ANALYSIS RESULTS OF THE EL5ML FOUND THAT THE INSTRUMENT WAS RECEIVED WITH THE RIGHT JAW BROKEN AT THE BIFURCATION. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIP. DUE TO THE CONDITION OF THE INSTRUMENT RETURNED, THE REPORTED EVENT COULD NOT BE CONFIRMED. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH RECORD WAS REVIEW AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE DEVICE JAMMED DURING FIRING. THEY DID NOT REPORT HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1