BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP CLIP APPLIER

    MDR report key: 5182358 · Received October 27, 2015

    Report

    Report Number
    3005075853-2015-06803
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 6, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # M91C0A. THE ER320 DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION. IN ADDITION, A BAG WITH NINE MALFORMED CLIPS WAS RETURNED ALONG WITH THE INSTRUMENT. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, ONE CLIP WAS EJECTED DUE TO THE CONDITION OF THE JAWS; FINALLY THE INSTRUMENT LOCKED OUT AS INTENDED. POSSIBLE CAUSES FOR THE FOUND CONDITION OF THE YIELDED JAWS MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: CAN YOU PLEASE CLARIFY WHAT YOU MEANT BY "DEVICE CLIPS DID NOT SIT PROPERLY IN THE JAWS OF THE APPLIER WHEN LOADED." WERE THE CLIPS IN THE JAWS SIDEWAYS? - AS DESCRIBED IN MY INITIAL REPORT, WHEN THE DEVICE WAS DRY FIRED THE CLIPS SHOT FORWARD OUT OF THE DEVICE AND DID NOT POSITION THEMSELVES IN THE JAWS OF THE INSTRUMENT WAITING TO BE APPLIED TO THE VESSEL. THE ONLY WAY THAT THE SGN GOT THE DEVICE TO WORK WAS BY POSITIONING THE EMPTY JAWED ER320 OVER THE VESSEL THEN SQUEEZING THE HANDLE AND RELYING ON THE TISSUE TO STOP THE CLIPS FROM SHOOTING OUT. A SUBSEQUENT SQUEEZE WOULD THEN APPLY THAT CLIP WHICH WAS FREQUENTLY POORLY POSITIONED IN THE JAWS OF THE APPLIER. YOU STATED THAT THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. WAS THERE ANY ISSUE WITH THE CLIPS THAT WERE FIRED? WERE ANY CLIPS MALFORMED? WERE ANY CLIPS SCISSORED? - YES, YES & YES. AS A RESULT OF THE CLIPS NOT WANTING TO WAIT IN THE JAWS BEFORE APPLYING THE SGNS EFFORTS TO RETAIN THE CLIPS IN THE JAWS RESULTED IN MALFORMED CLIPS, OF WHICH SEVERAL WERE SCISSORED. DID ANY OF THE CLIPS NOT HOLD ON TO THE VESSEL OR TISSUE? - YES, AS A RESULT OF BEING MALFORMED & SCISSORED. WHAT IS MEANT BY "THERE WAS NOT ANY APR"? THERE WAS NOT ANY ADVERSE PATIENT REACTION, THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY THE SGN USING THE SAME DEVICE. THE PATIENT WAS NOT COMPROMISED AS A RESULT OF THE MALFORMED CLIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, CLIPS DID NOT FEED PROPERLY AS REQUIRED FROM THE SHAFT OF THE DEVICE INTO THE JAWS OF THE INSTRUMENT PRIOR TO FIRING. EIGHT TIMES DEVICE CLIPS DID NOT SIT PROPERLY IN THE JAWS OF THE APPLIER WHEN LOADED. SEVERAL CLIPS FELL OUT OF THE APPLIER, AND WE'RE ALL SUCCESSFULLY RETRIEVED. WHEN THE SURGEON DRY-FIRED THE DEVICE, THE CLIPS SHOT FORWARD OUT OF THE INSTRUMENT ONTO THE FLOOR AND DID NOT POSITION THEMSELVES IN THE JAWS BEFORE BEING APPLIED ONTO THE VESSEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE. THE PATIENT WAS NOT COMPROMISED IN ANY WAY. THERE WAS NOT ANY "APR". THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712645 LIGACLIP CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA M4HJ72

    Patients

    Seq Age Sex Outcome Treatment
    1