BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LI

    MDR report key: 1024209 · Received March 27, 2008

    Report

    Report Number
    1527736-2008-01907
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    YIELDED JAWS. EVALUATION SUMMARY: THE ANALYSIS RESULTS CONFIRMED THAT THE JAWS ON THE ER320 HAD BECOME YIELDED CAUSING THE CLIPS TO BE EJECTED AND MAKING THE INSTRUMENT NON-FUNCTIONAL. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION AND TESTING. ALTHOUGH IT IS NOT POSSIBLE TO CONCLUDE HOW THE CIRCUMSTANCES OCCURRED, IT IS KNOWN FROM THE HISTORY OF THE INSTRUMENT THAT WHEN THE JAWS CLOSE ON A HARD OBJECT (NOT ORIGINAL DESIGN INTENT), THE INDUCED ELONGATION IN THE COMPONENT WILL EXCEED THE MATERIAL'S ELASTIC ZONE (COMPRESSION/TENSILE STRESSES INDUCED ON THE JAWS ARE HIGHER THAN ITS YIELD STRENGTH), HENCE THE JAW WIDTH WILL NOT RETURN TO ITS ORIGINAL DIMENSIONS/POSITION AFTER COMPLETION OF FIRE OUT. IN ADDITION AS PER THE INSTRUCTIONS FOR USE "NEVER FIRE THE INSTRUMENT OVER ANOTHER CLIP OR INSTRUMENT. FIRING THE INSTRUMENT IN THIS MANNER MAY DISTORT OR YIELD THE INSTRUMENT JAWS, WHICH CAN CAUSE THE INSTRUMENT TO "SPLIT" CLIPS". WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. 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 MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULD NOT CLOSE. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LI FZP ETHICON ENDO-SURGERY, INC. NA D4GR8A

    Patients

    Seq Age Sex Outcome Treatment
    1