BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1810045 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07527
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Report Date
    October 1, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): YIELDED JAW. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR THE ER320 INSTRUMENT FOUND THAT IT WAS RETURNED WITH THE JAWS YIELDED. THE INSTRUMENT WAS CYCLED, FED AND FORMED 4 CONFORMING CLIPS AND 1 CLIP WITH GAP. 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. 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. 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 "SPIT" CLIPS". THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT WORK. NO OTHER DETAILS ARE KNOWN. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1