BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI ENERGY

    MDR report key: 13623992 · Received February 28, 2022

    Report

    Report Number
    2955842-2022-10399
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    October 27, 2021
    Report Date
    February 1, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS UNABLE TO BE REPRODUCED DURING FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION, ENGAGEMENT, AND SELF-CHECK TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. ELECTRICAL CONTINUITY WAS TESTED AND PASSED. THE INSTRUMENT WAS CONNECTED TO THE E-100 GENERATOR AND WAS TESTED FOR ENERGY DELIVERY. THE E-100 GENERATOR DID NOT TURN OFF DURING IN-HOUSE TESTING AND NO INTERMITTENT SEALING WAS OBSERVED. THE GRIP FORCE TEST WAS PERFORMED AND PASSED SPECIFICATION. AS PART OF INVESTIGATION, ADDITIONAL UNRELATED FINDINGS WERE IDENTIFIED. THERMAL DAMAGE ON THE CUT ELECTRODE LOCATED ON THE BOTTOM JAW OF THE GRIP SET DUE TO A COMPONENT FAILURE, AND A DISLODGED JAW COVER AT THE PROXIMAL END. THE INSTRUMENT WAS FURTHER INVESTIGATED BY THE ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE). FAE INDICATED THAT THE E-100 GENERATOR SHUT DOWN IS RELATED TO A GENERATOR OVERCURRENT PROTECTION DURING ARCING EVENTS. INSTRUMENT INVESTIGATION RESULTS INDICATED A CUT ELECTRODE THERMAL DAMAGE, LIKELY DUE TO AN ARCING EVENT. MARKINGS ON THE INNER LOWER JAW SUGGESTS THAT THE ARC REMAINED WITHIN THE INSTRUMENT JAWS. THE ISSUE IS INDICATIVE OF A COMPONENT FAILURE. REVIEW OF THE E-100 GENERATOR LOGS IDENTIFIED (1) TWO CUT ELECTRODE SHORTED ERRORS, SUGGESTING THAT ARCING EVENTS OCCURRED AND (2) A SMARTSEAL ANGLE THRESHOLD ERRORS SUGGESTING THAT SEAL WAS ATTEMPTED WITH TOO MUCH TISSUE BETWEEN THE JAWS. ADDITIONALLY, FAE IDENTIFIED THAT ONE OF THE CERAMIC DOTS APPEARED TO BE BROKEN AND MISSING, WITH BURN MARKS INDICATING IT WAS DAMAGED DURING AN ARCING EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND PERFORMED A PROACTIVE REPLACEMENT OF THE E-100 GENERATOR. AFTER REPLACEMENT, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. FAILURE ANALYSIS OF THE E-100 GENERATOR WITH AN IN-HOUSE SYSTEM FOUND NO FUNCTIONAL ISSUE. THE E-100 GENERATOR WAS TESTED WITH AN IN-HOUSE SYNCHROSEAL INSTRUMENT. THE INSTRUMENT WAS ENERGIZED AND FUNCTIONED PROPERLY FOR THE SYNC ACTIVATION AS WELL AS THE CUT AND CAUTERY FUNCTIONS. INSTRUMENT WAS TESTED MULTIPLE TIMES AND OPERATED AS EXPECTED. E-100 GENERATOR WAS OPERATED FOR AN EXTENDED PERIOD OF TIME AND FUNCTIONED WITHIN SPECIFICATION. A REVIEW OF THE SITE'S COMPLAINT HISTORY SHOWS ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE INSTRUMENT LOGS FOR THE SYNCHROSEAL INSTRUMENT LOT# L90210718 / SEQUENCE 0382 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE OF (B)(6) 2021 ON SYSTEM SK3870. THE INSTRUMENT IS SINGLE USE AND NO SUBSEQUENT USE RECORDED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: FA ACKNOWLEDGES THAT A FRAGMENT WAS MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END); HOWEVER, THE SITE REPORTED THAT NO FRAGMENT FELL INTO THE PATIENT. WHILE THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS UNINTENDED FRAGMENT(S) FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE E-100 GENERATOR CONNECTED TO A SYNCHROSEAL INSTRUMENT POWERED OFF. THE COMPLAINT ALLEGES THAT THE GENERATOR POWERED OFF THEREFORE THERE IS NO ENERGY DELIVERED. THERE IS NO RISK OF ANY ADVERSE EVENT RELATED TO AN UNINTENDED ENERGY DISCHARGE TO THE PATIENT. TROUBLESHOOTING WAS PERFORMED. THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INTO THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862598 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-05 L90210718 0382 10886874117306

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES