BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3005075853-2011-00325

    MDR report key: 1971706 · Received January 27, 2011

    Report

    Report Number
    3005075853-2011-00325
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SENT TO (B)(4) FOR REVIEW. THE CAM WAS ANALYZED WITH AN OPTICAL MICROSCOPE AND IMAGES WERE TAKEN OF THE COMPONENT. THE CRACK HAD PROCEEDED ALONG THE LENGTH OF THE REGION WHERE THE JAW INTERACTS WITH CAM SURFACE. THE SMALL SECTION OF THE CAM WAS BROKEN FROM THE BASE IN ORDER TO EXAMINE THE FRACTURE. THE PART WAS THEN EXAMINED IN THE SCANNING ELECTRON MICROSCOPE (SEM). THE CRACKED SECTION IS SLIGHTLY ELEVATED ABOVE THE BASE SURFACE. THE FRACTURE SURFACE REVEALED THAT THE PART BROKE IN A BRITTLE TRANSGRANULAR MODE. ONE POSSIBLE CAUSE FOR THIS FAILURE MODE IN A STAINLESS STEEL IS THAT IT HAD BEEN EXPOSED TO AN ENVIRONMENT THAT CREATED A STRESS CORROSION CONDITION. THE PRESENCE OF CHLORINE CONTAINING FLUIDS SUCH AS SALINE AND BODY FLUIDS CAN CREATE THIS CONDITION BUT PROBABLY NOT IN THE SHORT AMOUNT OF TIME THAT THE CAM WAS EXPOSED TO THESE FLUIDS IN SURGERY. HOWEVER, THIS CONDITION COULD OCCUR BY EXPOSING THE COMPONENT TO THESE FLUIDS AND THEN SHIPPING THE PART AND FIRING IT LATER, SUCH AS IN THE PI LAB. THE INITIAL EVENT DESCRIPTION STATED THAT THE DEVICE WOULD NOT RELEASE AFTER FIRING. THERE CAN BE MULTIPLE CAUSES FOR THIS AND IT IS UNCERTAIN WHAT THE CAUSE WAS FOR THIS DEVICE. WHEN THE DEVICE WAS FIRST FIRED IN THE PI LAB IT WAS NOTED THAT THE DEVICE DOUBLE FED. A DOUBLE FEED TYPICALLY WOULD NOT OCCUR DUE TO A CRACKED CAM. IF THERE WAS A DOUBLE FEED INCIDENT IN THE HOSPITAL AND THE DEVICE WAS FIRED, A JAMMED JAW CONDITION COULD HAVE OCCURRED. MULTIPLE FIRINGS PRODUCED CLIPS OF VARYING QUALITY BUT THE OPERATOR NOTED THAT IN SOME OF THE FIRINGS THE TRIGGER HAD TO BE MANUALLY RETURNED. IT IS NOT CERTAIN THE CAUSE OF THE CAM FRACTURE OR AT ONE TIME IT OCCURRED, BUT ONE LIKELY SCENARIO IS THE CAM CRACKED IN THE PI LAB DURING ONE OF THE FIRINGS. THE ACTUAL CAUSE OF THE ORIGINAL JAW STICKING ISSUE IS UNCLEAR.

    Additional Manufacturer Narrative · 1

    (B)(4): OPENING ISSUES, CAM. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, A DOUBLE FEED INCIDENT OCCURRED. IT IS POSSIBLE THAT THE FEEDING ISSUE OCCURRED AS A RESULT OF THE TRIGGER NOT ENGAGING THE ANTI-BACKUP RATCHET PRIOR TO RELEASING; HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND CONDITION. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. DURING THE SECOND FIRING SEQUENCE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP CAUSING THAT THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; A PEAR SHAPED CLIP WAS RELEASED. THE DEVICE WAS DRY FIRED AND TWO CONFORMING CLIPS WERE RELEASED; HOWEVER, THE JAWS REMAINED PARTIALLY OPENED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS. AS ADDITIONAL TESTING, THE DEVICE WAS DRY FIRED ONCE AND TWO TIMES OVER THE TEST CATHETER ACCORDING TO THE RECOMMENDATION FOR A CHOLANGIOGRAM PROCEDURE; THE CLIPS WERE FORMED AS INTENDED. HOWEVER, DURING EACH FIRING SEQUENCE, THE JAWS REMAINED PARTIALLY OPENED. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS. IN ORDER TO EVALUATE THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, ONE JAW CAM RAMP WAS NOTED TO BE BROKEN LEADING THAT THE JAWS REMAINED PARTIALLY OPENED DURING FIRING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FZP ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1