BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FZP CLIP, IMPLANTABLE

    MDR report key: 1471659 · Received June 16, 2009

    Report

    Report Number
    3005075853-2009-03563
    Event Type
    Malfunction
    Date Received
    June 16, 2009
    Date of Event
    January 1, 2009
    Report Date
    May 27, 2009
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION. ONE J FORMED CLIP WAS RECEIVED INSIDE A PLASTIC BAG, HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHY THE CLIP WAS NOT PROPERLY FORMED. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECS. THE INSTRUMENT LOCKED OUT AS INTENDED. A ROOT CAUSE THE MALFORMED CLIP IS FEEDING THE CLIP INTO A CLOSED SET OF JAWS. THE FOLLOWING ARE SCENARIOS OF HOW THIS MALFORMED CLIP COULD HAVE HAPPENED: HAVING THE JAWS CLOSED IN A TROCAR AND ACTUATING THE TRIGGER. HAVING THE JAWS CLOSED IN THE MOLDED ENDCAP AND ACTUATING THE TRIGGER. HAVING THE JAWS CLOSED BY BURYING TIPS IN TISSUE AND ACTUATING THE TRIGGER. IT SHOULD BE NOTED THAT THE JAWS NEED TO BE FULLY OPEN IN ORDER FOR THE NEXT CLIP TO BE PROPERLY FED. 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. THE ANALYSIS RESULTS CONFIRMED THAT ONE DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED AND FORMED THE REMAINING CLIPS WITHIN MFG SPECS. THE INSTRUMENT LOCKED OUT AS INTENDED, BUT THE ORANGE INDICATOR DID NOT SHOW UP COMPLETELY. 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 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. DEVICE B: BATCH#=F9G11U, MFG DATE: 01/30/2009; EXP DATE: 12/30/2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE FIRED A MALFORMED CLIP, DID NOT CLOSE TIGHT ENOUGH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1