BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTRUMENT, ULTRASONIC SURGICAL

    MDR report key: 5629061 · Received May 3, 2016

    Report

    Report Number
    3005075853-2016-02438
    Event Type
    Injury
    Date Received
    May 3, 2016
    Date of Event
    March 31, 2016
    Report Date
    March 31, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K132612
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PRODUCT SPECIALIST HAS FURTHER ADVISED THAT THE PATIENT HAS DEVELOPED A POST OPERATIVE NERVE PALSY. ADDITIONAL INFORMATION REQUESTED BUT UNAVAILABLE: WHY DOES THE SURGEON BELIEVE THAT THE NERVE PALSY WAS ASSOCIATED WITH THE HARMONIC DEVICE? WHAT HEAT MANAGEMENT TECHNIQUES WERE USED DURING THE SURGERY? WHAT PRECAUTIONARY STEPS WERE DONE TO PROTECT THE LARYNGEAL NERVES? THE DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE DEVICE WAS CONNECTED TO A TEST HANDPIECE AND TESTED ON A GEN11, THE GENERATOR IMMEDIATELY DISPLAYED THE "REPLACE INSTRUMENT" ALERT SCREEN AND THE DEVICE COULD NOT BE ACTIVATED FOR FURTHER FUNCTIONAL TESTING. THE DEVICE WAS ANALYZED, AND IT WAS DETERMINED THAT IT WAS LIKELY CONNECTED IN MORE THAN ONE GENERATOR. THE DEVICE IS INTENDED AND LABELED FOR SINGLE PATIENT USE. IF THE DEVICE IS CONNECTED TO MULTIPLE GENERATORS AN ALERT SCREEN WILL BE DISPLAYED INDICATING ¿REPLACE INSTRUMENT¿. DUE TO THE CONDITION OF THE DEVICE, WE ARE UNABLE TO INVESTIGATE FURTHER THE ¿RESTART GENERATOR AND SWITCH ERROR SCREEN DISPLAYED WITH GEN11¿. HOWEVER, THE ATT OFF DID NOT CAUSE THE ¿RESTART GENERATOR AND SWITCH ERROR SCREEN DISPLAYED WITH GEN11¿. THIS DEVICE IS PACKAGED AND STERILIZED FOR SINGLE USE ONLY. MULTIPLE PATIENT USES MAY COMPROMISE THE DEVICE INTEGRITY OR CREATE A RISK OF CONTAMINATION THAT, IN TURN, MAY RESULT IN PATIENT INJURY OR ILLNESS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT LOG SUMMARY: ON GEN11 S/N (B)(4) A PARTICULAR HAR9F/ HPBLUE COMBINATION SHOWS MANY INSTANCES OF RECOVERY FROM THE DISCONNECT GRACE PERIOD, WHICH CAN BE INDICATIVE OF HAND PIECE/INSTRUMENT CONNECTIVITY ISSUES. TOWARDS THE END OF THIS SEQUENCE MULTIPLE INSTANCES OF INSTRUMENT EEPROM WRITE FAILURES WERE RECORDED BEFORE A SIGNAL_MIT_FAILURE_DATA_MISMATCH FAULT OCCURRED, WHICH REQUIRES A RESTART OF THE GEN11. THE GEN11 WAS RESTARTED AND THE SAME HAR9F/HPBLUE COMBINATION IS SEEN PASSING AIT. AS WITH THE PREVIOUS SEQUENCE THERE ARE MULTIPLE INSTANCES OF ENABLING THE RECOVERY OF THE DISCONNECT GRACE PERIOD, WHICH WOULD INDICATE CONTINUED CONNECTIVITY ISSUES BETWEEN THE HP & INSTRUMENT. THERE WERE ALSO MULTIPLE RECORDED WRITE FAILURES. AS ACTIVATION ATTEMPTS ARE CONTINUED WITH MULTIPLE INSTANCES OF ENABLE/RECOVERY OF THE DISCONNECT GRACE PERIOD AS WELL AS EEPROM WRITE FAILURES, INSTANCES OF SIGNAL_HANDSWITCH_UNKNOWN_FAULT ARE RECORDED, WHICH WOULD PRESENT AS A REPLACE INSTRUMENT ERROR SCREEN. IT APPEARS THE INSTANCES OF SIGNAL_HANDSWITCH_UNKNOWN_FAULT WERE INTERMITTENT AT FIRST BUT BECAME STEADILY MORE FREQUENT. AS THE FREQUENCY OF THESE ERROR SCREENS BECOME MORE PREVALENT A DATA MISMATCH ERROR OCCURS TRIGGERING THE GEN11 TO RESTART. IT APPEARS THAT ONCE THE GEN11 WAS RESTARTED THEY ATTEMPTED TO USE THIS SAME COMBINATION OF HAR9F/HPBLUE BUT A REPLACE INSTRUMENT FAULT OCCURRED SPECIFIC TO A PROBLEM WITH THE INSTRUMENT EEPROM. BASED ON REVIEW OF THE EVENT & ENTRIES IN EVENT LOGS IT APPEARS THE SAME COMBINATION OF HP & INSTRUMENT THAT WAS PRODUCING THE ERROR ON THE 1ST GEN11 WAS TRIED ON ANOTHER GEN11 S/N (B)(4). THE EVENT LOG INDICATED THE SAME INSTRUMENT ERROR OCCURRED AGAIN. IT THEN APPEARS THEY ATTEMPTED TO SWITCH THE INSTRUMENT TO A DIFFERENT HP WITH THE SAME INSTRUMENT ERROR OCCURRING AGAIN. THE LOG THEN SHOWS A NEW INSTRUMENT WAS ATTACHED TO THE SAME HP SUCCESSFULLY PASSED THE PRE-RUN TEST, & WAS ABLE TO BE ACTIVATED SUCCESSFULLY MULTIPLE TIMES WITH NO FURTHER ERROR. CONCLUSION: ALTHOUGH IT IS DIFFICULT TO STATE DEFINITIVELY WITHOUT ANALYZING THE PARTICULAR HAND PIECE AND INSTRUMENT INVOLVED IN THE COMPLAINT IT IS SUSPECTED THAT CONNECTIVITY ISSUES BETWEEN THE HPBLUE HAND PIECE AND HAR9F INSTRUMENT LIKELY LED TO CORRUPTION OF THE INSTRUMENT EEPROM. ONCE THE INSTRUMENT EEPROM BECOMES CORRUPT THE GEN11 WILL PRODUCE A REPLACE INSTRUMENT ERROR WHEN IT TRIES TO IDENTIFY THE INSTRUMENT. GENERATOR EVENT LOG PROVIDE:

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A THYROIDECTOMY PROCEDURE, "CUSTOMER REPORTED THE FOLLOWING SEQUENCE OF EVENTS THAT RESULTED IN ANOTHER HARMONIC FOCUS+ BEING OPENED TO COMPLETE THE PROCEDURE: RESTART GENERATOR ERROR RESULTED IN GENERATOR #1 BEING RESTARTED. ERROR RELATING TO BOTH ACTIVATION BUTTONS ON INSTRUMENT DISPLAYING ON SCREEN. REPLACE INSTRUMENT ERROR. BEFORE REPLACING THE INSTRUMENT THEY SWAPPED THE GENERATOR FOR THEIR SPARE GENERATOR WITH NO CHANGE; THEY ALSO TRIED A NEW HPBLUE TO SEE IF THAT WAS THE ISSUE WITH NO RESULT. UPON REPLACEMENT OF THE INSTRUMENT THE PROCEDURE CONTINUED AS NORMAL WITH NO FURTHER ERRORS DISPLAYING. THERE WAS A DELAY OF TEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283837 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK M4HU5K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other