BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1202740 · Received October 17, 2008

    Report

    Report Number
    3005075853-2008-02425
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    July 31, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN CAM. DEVICE B ADDITIONAL INFORMATION: BATCH # E9ET10. EXPIRATION DATE: 02/2013. MANUFACTURING DATE: 03/2008. MALFORMED CLIP. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOR DEVICE A FOUND THAT IT WAS RETURNED WITH THE CAM BROKEN. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE CAM CONDITION. A PRELIMINARY INVESTIGATION PROCESS HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE BROKEN CAM ISSUES. NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY CAUSED THE EVENT REPORTED AS THE CAM CONDITION DOES NOT ALLOW THE INTENDED CLOSURE OF THE JAWS. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW. THE ANALYSIS RESULTS FOR THE DEVICE B CONFIRMED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND FED ONE PEAR SHAPED CLIP, THREE CONFORMING CLIPS, AND THEN THE JAWS JAMMED IN THE CLOSED POSITION (THE TRIGGER HAD TO BE MANUALLY ASSISTED TO RE-OPEN THE JAWS), THE INSTRUMENT THEN FORMED ONE PEAR SHAPED CLIP AND THE REMAINING FOUR CLIPS WERE CONFORMING. A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE ROOT CAUSE OF THE JAWS OPENING ISSUES. ADDITIONALLY THE ORANGE INDICATOR DID NOT SHOWED UP COMPLETELY. THE INSTRUMENT IS DESIGNED TO LOCKOUT WHEN ALL THE CLIPS HAVE BEEN FIRED AND THE ORANGE INDICATOR MUST BE VISIBLE AFTER THE 13TH CLIP IS FIRED. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE THE DEVICE FIRED, BUT WOULD NOT OPEN. THE DEVICE WAS REMOVED FROM THE TISSUE BY EXCISION. A SECOND DEVICE WAS PULLED AND THE DEVICE STUCK ON TISSUE, BUT WAS ABLE TO BE FORCED OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE CASE WAS EXTENDED BY AN ADDITIONAL 15 MINUTES. THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention