BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1130330 · Received August 20, 2008

    Report

    Report Number
    3005075853-2008-01307
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    April 14, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLIPS. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (A) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED 8 CLIPS CONFORMING, HOWEVER, AFTER THE EIGHT FIRING THE REMAINING CLIPS WERE EJECTED. THE INSTRUMENT LOCK OUT WAS FUNCTIONAL. THE ANALYSIS RESULTS FOUND THAT THE ER420 INSTRUMENT (B) WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED 6 CLIPS CONFORMING, HOWEVER, AFTER THE SIXTH FIRING THE REMAINING CLIPS WERE EJECTED. THE INSTRUMENT LOCK OUT WAS FUNCTIONAL. 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 FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE COMPLAINT WRITTEN ON THE BOXES SAID "MISFIRED" THAT IS ALL THE INFO GIVEN. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL FZP ETHICON ENDO-SURGERY, LLC NA D4HC2U

    Patients

    Seq Age Sex Outcome Treatment
    1