BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 7316391 · Received March 6, 2018

    Report

    Report Number
    9612501-2018-00335
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    March 11, 2017
    Report Date
    March 5, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    UDI-DI
    20884521057859
    PMA / PMN Number
    K071406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY REPORTED TO THE FDA ON A SUMMARY REPORT. DUE TO NEW INFORMATION BEING RECEIVED, IT IS NOW BEING SUBMITTED ON A 3500A. (B)(4) MANUFACTURING FACILITY ((B)(4)) RECEIVED ONE USED SAMPLE FROM ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L (PRODUCT ID 176630) PRODUCT WAS RECEIVED AT (B)(4) FACILITY FOR FURTHER EVALUATION DUE TO ¿JAWS WILL NOT OPEN. THE DEVICE WAS RECEIVED PARTIALLY DISSEMBLED. THE INSTRUMENT HANDLE WAS FLACCID, AS RESULT THE INSTRUMENT WAS UNABLE TO BE CYCLED. THE DEVICE WAS DISASSEMBLED FOR VISUALIZATION OF INTERNAL COMPONENTS AND IT WAS OBSERVED THAT THE WISHBONE HAD DISCONNECTED FROM THE TRIGGER HANDLE. PMV FOUND THE WISHBONE LINK (P/N PT00003064) DISCONNECTED FROM THE TRIGGER HANDLE. ON PREVIOUS INVESTIGATION REPLICATION EXERCISES DEMONSTRATED THAT THE DEVICE MIGHT JAM IF THE TRIGGER HANDLE IS NOT ALLOWED TO FULLY RETURN TO THE HOME POSITION AFTER FORMING A PREVIOUS CLIP AND IT IS IMMEDIATELY SQUEEZED. ONCE THE HANDLE IS JAMMED, THE WISHBONE DISENGAGEMENT COULD HAVE HAPPENED IF THE HANDLE WAS OPENED BY USER MANUALLY. THE VISUAL INSPECTION OF THE WISHBONE AND THE TRIGGER HANDLE NOTED MARKS EVIDENCING THAT THE INSTRUMENT WAS MANIPULATED. DUE TO THE CONDITION OF THE HANDLE AND WISHBONE, THE SAMPLE COULD NOT BE FUNCTIONALLY EVALUATED. THOSE PARTS (WISHBONE AND TRIGGER HANDLE) WERE REASSEMBLED AND DUE TO THE CONDITION OF THE HANDLE AND WISHBONE, THESE CANNOT BE PROPERLY ANCHORED. THE ASSEMBLY OPERATOR AND 100% FIRE TEST WHERE THE DEVICE IS INSERTED IN THE NEST OF THE TEST FIRE MACHINE AND THE FIRST TWO CLIPS ARE FIRED TO VERIFY THEM. THIS IS A VALIDATED AND AUTOMATIC PROCESS. THESE COMPONENTS (HANDLE AND WISHBONE) ARE DIRECTLY RELATED TO THE PROPER FUNCTIONING OF THE JAW. IN ANOTHER ATTEMPT TO EVALUATE THE FUNCTIONALITY OF THE DEVICE, THE ASSEMBLY OF THE JAW WITH THE TUBE AND THE OTHER COMPONENTS WERE ASSEMBLED WITH A NEW HANDLE AND WISHBONE AND NEW CLIPS WERE LOADED INTO THE CHANNEL. THE HANDLE WAS PROPERLY RETRACTED AND THE DEVICE COULD BE ACTUATED. THE JAW OPEN AND CLOSED PROPERLY. BASED ON ASSESSMENT CONDUCTED IN THIS INVESTIGATION, THERE IS NO EVIDENCE TO ATTRIBUTE THE WISHBONE DISENGAGEMENT OR THE JAWS NOT OPENING TO ASSEMBLY OR SUPPLIER PROCESS. IN RELATION WITH THE JAWS NOT OPENING CONDITION EXPERIENCED BY THE COSTUMER INSTRUCTION FOR USE OF ENDOCLIP III PRODUCTS CLEARLY INDICATES ¿WHEN FIRING THE INSTRUMENT, SQUEEZE THE HANDLE FIRMLY AS FAR AS IT WILL GO. FAILURE TO SQUEEZE THE HANDLE COMPLETELY MAY RESULT IN AN IMPROPERLY FORMED CLIP AND POSSIBLE BLEEDING AND/OR LEAKAGE. FAILURE TO SQUEEZE THE HANDLES COMPLETELY MAY PREVENT THE JAWS FROM OPENING.¿ NO FURTHER ANALYSIS IS REQUIRED FOR THIS CASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC CHOLEDOCHOLITHOTOMY, THE JAWS OF THE DEVICE WOULD NOT OPEN. THE SURGEON WAS ABLE TO SQUEEZE THE HANDLES OF THE DEVICE WHEN THE ISSUE OCCURRED AND THE JAWS WERE STILL ABLE TO CLOSE. TO COMPLETE THE PROCEDURE, ANOTHER CLIP APPLIER WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160815 ENDO CLIP III CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176630 J6C2448X 20884521057859

    Patients

    Seq Age Sex Outcome Treatment
    1