BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1122028 · Received August 14, 2008

    Report

    Report Number
    3005075853-2008-01205
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 21, 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
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT B: BATCH #: E9F18J; EXP DATE: 04/21/20013; MFR DATE: 05/21/2008; THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING SPECIFICATIONS. THE INSTRUMENT LOCKED OUT AS INTENDED. 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 INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED 6 CLIP CONFORMING AND 1 MALFORMED CLIP DUE TO BYPASS ISSUES. IN ADDITION, THE ORANGE INDICATOR DID NOT SHOWED UP AFTER THE DEVICE LOCKED OUT. WHILE NO CONCLUSION COULD BE REACHED AS TO WHY THE BYPASS ISSUES OCCURRED. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS PRE-FIRED FINE OUTSIDE THE PATIENT, BUT ONCE INSERTED INTO THE PATIENT, IT WOULD NOT FIRE. A SECOND DEVICE WAS OPENED AND THE SAME THING OCCURRED. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO-SURGERY, LLC NA E4L55H

    Patients

    Seq Age Sex Outcome Treatment
    1