BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC HD 1000I SHEARS 36CM SHAFT

    MDR report key: 10732998 · Received October 26, 2020

    Report

    Report Number
    3005075853-2020-05550
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    March 11, 2020
    Report Date
    September 29, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036015055
    PMA / PMN Number
    K160752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/19/2020 DIFFERENT INVESTIGATION SUMMARY THAN WHAT WAS ORIGINALLY REPORTED: CORRECTION MEDWATCH. H10: CORRECTED DATA = H10 INVESTIGATION SUMMARY THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED WITH AN EMBEDDED STAPLE AND 100% PRESENT, THE BLADE TIP WAS DAMAGED, HOWEVER, THE BLADE WAS NOT CRACKED. ADDITIONALLY, THE DEVICE WAS RECEIVED WITH THE CABLE CUT OFF. DUE TO THE CONDITION OF THE DEVICE MOST FUNCTIONAL TESTING COULD NOT BE CONDUCTED, HOWEVER, THERE WAS NO AUDIBLE FEEDBACK SOUND FROM THE INSTRUMENT WHEN THE CLAMP ARM WAS FULLY CLOSED. THE INSTRUMENT WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS AND THE CLOSURE INDICATOR WAS MISSING. ADDITIONALLY, ONE OF THE SHROUD POSTS APPEARED TO BE DAMAGED, WHICH SEEMS TO PREVENTED IT FROM LOCKING INTO THE OPPOSITE SHROUD THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IF THE DEVICE IS ACTIVATED ACROSS A CLIP, STAPLE LINE OR OTHER METAL IN THE JAWS, IT IS POSSIBLE THAT THE GENERATOR WILL DISPLAY AN ALERT SCREEN, AND AFTER RECEIVING TWO CONSECUTIVE ALERTS SCREENS A "REPLACE INSTRUMENT" ALERT SCREEN WILL BE DISPLAYED BY THE GENERATOR. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. THIS IN TURN CAN RESULT IN ACTIVATION ISSUES SUCH AS FAILING THE PRE-RUN TEST WITH THE GENERATOR AND DISPLAYING AN ALERT SCREEN. THESE ALERT SCREENS THAT CAN RESULT ARE SUCH AS ¿BLADE ERROR DETECTED¿ OR "RELAXED PRESSURE ON BLADE" FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. CONTINUED USAGE OF THE DAMAGE BLADE CAN RESULT IN A BROKEN BLADE. FURTHER ANALYSIS; THE EXACT POINT AT WHICH THE CLICKER CAME TO BE MISSING FROM THE DEVICE COULD NOT BE CONCLUDED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CLICKER WAS NOT PRESENT WHEN THE USER HAD THE DEVICE. FURTHER INVESTIGATION HAS BEEN INITIATED AND RECORDED UNDER NR-0150522. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    (B)(4); BATCH # U9356F. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED WITH THE TISSUE PAD DAMAGED WITH AN EMBEDDED STAPLE AND 100% PRESENT, THE BLADE TIP WAS DAMAGED, HOWEVER, THE BLADE WAS NOT CRACKED. ADDITIONALLY, THE DEVICE WAS RECEIVED WITH THE CABLE CUT OFF. DUE TO THE CONDITION OF THE DEVICE MOST FUNCTIONAL TESTING COULD NOT BE CONDUCTED, HOWEVER, THERE WAS NO AUDIBLE FEEDBACK SOUND FROM THE INSTRUMENT WHEN THE CLAMP ARM WAS FULLY CLOSED. THE INSTRUMENT WAS DISASSEMBLED TO INSPECT INTERNAL COMPONENTS, AND THE CLOSURE INDICATOR WAS MISSING. ADDITIONALLY, ONE OF THE SHROUD POSTS APPEARED TO BE DAMAGED, WHICH SEEMS TO PREVENTED IT FROM LOCKING INTO THE OPPOSITE SHROUD THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IF THE DEVICE IS ACTIVATED ACROSS A CLIP, STAPLE LINE OR OTHER METAL IN THE JAWS, IT IS POSSIBLE THAT THE GENERATOR WILL DISPLAY AN ALERT SCREEN, AND AFTER RECEIVING TWO CONSECUTIVE ALERTS SCREENS A "REPLACE INSTRUMENT" ALERT SCREEN WILL BE DISPLAYED BY THE GENERATOR. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE THE SEVERITY OF THE BLADE DAMAGE. THIS IN TURN CAN RESULT IN ACTIVATION ISSUES SUCH AS FAILING THE PRE-RUN TEST WITH THE GENERATOR, AND DISPLAYING AN ALERT SCREEN. THESE ALERT SCREENS THAT CAN RESULT ARE SUCH AS, ¿BLADE ERROR DETECTED¿, OR "RELAXED PRESSURE ON BLADE", FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE. CONTINUED USAGE OF THE DAMAGE BLADE CAN RESULT IN A BROKEN BLADE. FURTHER ANALYSIS COMPLETED; WE HAVE AN ANALYSIS FINDING THAT THE CLICKER WAS MISSING. IT IS POSSIBLE THAT THE CLICKER, IF PRESENT AT THE TIME THE DEVICE WAS OPENED, COULD HAVE FALLEN OUT. SPRINGS AND CLICKERS COMMONLY FALL OUT WHEN DISASSEMBLING DEVICES, AND IT IS PRESUMED THAT WHEN THE CLICKER WAS IDENTIFIED AS MISSING, THE ROOM WOULD HAVE BEEN BRIEFLY SEARCHED. GIVEN THAT, WE CAN ONLY ASSUME THE CLICKER WAS MISSING WHEN THE DEVICE WAS OPENED. THE LIKELIHOOD THAT THE CLICKER COULD MIGRATE OUT DURING TRANSIT WAS DISCUSSED. IF PROPERLY SEATED IN THE RIBS, THERE IS NO WAY FOR THE CLICKER TO MIGRATE OUT ABSENT OF THE SHROUDS BECOMING COMPLETELY DISASSEMBLED. THE CLICKER WOULD HAVE TO TRAVERSE THE ENTIRE WIDTH OF THE CLICKER TO UNSEAT FROM THE RETENTION RIBS. IF DAMAGED/BROKEN THERE WOULD STILL BE REMNANTS OF IT CAPTURED IN THE RIBBING. THERE IS A VISION SYSTEM CHECK ON THE LINE TO VERIFY IT IS PRESENT BEFORE THE LEFT SHROUD IS PLACED ON TOP AND PRIOR TO ENTERING THE CONVEYOR FOR THE MAS LINE HANDLE PRESS. IT IS POSSIBLE THAT THE CLICKER CAN POP OUT OF THE RIBBING DURING CONVEYANCE. IF IT POPS OUT INTO THE SHROUDS, IT WOULD BE LOOSE AND COULD MIGRATE OUT OF THE TRIGGER OPENING. IT COULD ALSO POP OUT OF THE SHROUDS ENTIRELY BEFORE PRESSED. BOTH CONDITION SHOULD BE CAUGHT AT THE END OF THE LINE CHICKI-CHIKI TEST. THE EFFECTIVENESS OF THE 100% INSPECTION HAS BEEN NOTED. OUR MANUFACTURING PROCESS HAS BEEN IDENTIFIED AS THE ROOT CAUSE OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CANCER SURGERY, THE DOCTOR WAS USING THE HARHD20 INSTRUMENT, AND KEPT GETTING CLEAN BLADE MESSAGE. THE BLADE WAS CLEANED, AND THE MESSAGE KEPT RETURNING. A SECOND LIKE DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197285 HARMONIC HD 1000I SHEARS 36CM SHAFT INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARHD36 10705036015055

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| GENERATOR