BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ENERGY

    MDR report key: 16250293 · Received January 26, 2023

    Report

    Report Number
    2955842-2023-10338
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 3, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874117306
    PMA / PMN Number
    K191280
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION FOUND THE PRIMARY FAILURE OF BROKEN PLASTIC OVERMOLD OF THE GRIP TIPS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PLASTIC OVERMOLD OF THE GRIP TIPS. A PIECE APPROXIMATELY 0.047" X 0.067" WAS NOT RETURNED WITH THE INSTRUMENT. A REVIEW OF THE LOG SHOWS NO ERRORS. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE THAT WAS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT WAS ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE TO THE CUT ELECTRODE OF THE GRIP TIPS. COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO A COMPONENT FAILURE. THE INSTRUMENT WILL BE TRANSFERRED TO ENGINEERING FOR FURTHER INVESTIGATION. IN ADDITION, THE JAW COVER WAS CUT DURING INSPECTION IN ORDER TO DETERMINE IF ANY FRAGMENTS WERE MISSING FROM THE PLASTIC OVERMOLD. THE RETURNED SYNCHROSEAL INSTRUMENT WAS FURTHER EVALUATED BY THE ADVANCED FAILURE ANALYSIS (AFA) ENGINEERING TEAM ON 03-MAR-2023. THE ENGINEERING TEAM CONFIRMED THE PRIMARY FAILURE ANALYSIS FINDINGS. THE INSTRUMENT EXHIBITS A BROKEN OVERMOLD COMPONENT FROM THE GRIP TIP. THE OVERMOLD WAS INSPECTED AND PLACED ON THE BREAK SITE TO DETERMINE IF ANY FRAGMENTS WERE MISSING. IT DOES NOT APPEAR TO BE ANY OBVIOUS MISSING PIECES FROM THE OVERMOLD AND THERE DOES NOT APPEAR TO BE MISSING FRAGMENTS THAT WERE BROKEN OFF AND NOT RETURNED. THE MATCHING JAW SET HAS AN UPPER JAW OVERMOLD WHICH IS ATTACHED USING A HEAT STAKE, AND THERE IS NO WASHER OR OTHER HARDWARE THAT COULD HAVE BECOME DISLODGED WHEN THE OVERMOLD BROKE. THE POTENTIAL FOR FRAGMENTS IS LIKELY ¿NO¿, SINCE IT APPEARS ALL FRAGMENTS HAVE BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. ISI HAS NOT RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT FELL INSIDE THE PATIENT. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF THE SYNCHROSEAL INSTRUMENT FELL OFF DURING THE OPERATION WHEN REMOVING IT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. NO POST OPERATIVE TESTS WERE PERFORMED. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES. INTUITIVE SURGICAL (IS) CONTACTED THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. THE FRAGMENT THAT FELL INTO THE PATIENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH A GRASPER. THE INSTRUMENT/ACCESSORY WAS INSPECTED PRIOR TO USE, AND THERE WAS NO DAMAGE OUT OF THE ORDINARY. THE INSTRUMENT WAS IN USE FOR 5 MIN PRIOR TO THE ISSUE OCCURRING. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT AND THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIALS DURING THE PROCEDURE. THE FRAGMENT FELL OFF WHEN IT WAS IN THE PORT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON THE REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA AFTER THE EVENT OCCURRED. ALL FRAGMENTS WERE RETRIEVED, AND IT WAS CONFIRMED THAT THE PIECE FIT THE SYNCROSEAL. THE INSTRUMENT AND THE FRAGMENT WILL BE RETURNED BACK TO ISI. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110570 DA VINCI ENERGY SYNCHROSEAL NAY INTUITIVE SURGICAL, INC 480440-06 L91220417 10886874117306

    Patients

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