BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14842103 · Received June 28, 2022

    Report

    Report Number
    2955842-2022-12501
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    July 1, 2021
    Report Date
    July 1, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE ARE NO INSTRUMENTS EXPECTED FOR RETURN TO ISI AS THERE WAS NO ALLEGATION OF A DA VINCI PRODUCT MALFUNCTION. THERE WAS NO REPORT OF AN INJURY REQUIRING ADMINISTRATION OF ANY MEDICAL INTERVENTION. UNSPECIFIED 3RD PARTY LAP SCISSORS INSTRUMENT ARC PRIOR TO ALL DA VINCI PORTS BEING PLACED AND PRIOR TO DA VINCI FOLLOWING MODE BEING ACHIEVED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. A REVIEW OF THE SYSTEM LOGS FOR THE EVENT DATE OF (B)(6) 2021 HAS BEEN PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) POST MARKET SURVEILLANCE SPECIALIST AND THE FOLLOWING WAS OBSERVED: THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND THE LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE INSTRUMENT ARCED AND RESULTED IN A ¿SLIGHT MARK; LIKE A SLIGHT BURN¿ ON PERITONEAL TISSUE NEAR THE ROBOTIC PORT SITE WHICH WAS SLIGHTLY WHITE IN APPEARANCE AND THE SIZE OF A PIN MARK, DESCRIBED AS LESS THAN A ONE-DEGREE BURN. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BENIGN HYSTERECTOMY DA VINCI-ASSISTED SURGICAL PROCEDURE, WHILE USING THE ERBE GENERATOR AND A LAPAROSCOPIC SCISSORS INSTRUMENT THROUGH A DA VINCI PORT, THERE WAS ARCING WHICH RESULTED IN A ¿SLIGHT BURN ON THE PATIENT¿. THERE WAS A REPORT THAT ¿THE METAL SCISSOR TIP¿ WAS POSSIBLY ¿TOUCHING THE CANNULA¿. THE CUSTOMER STOPPED USING THE ERBE GENERATOR AND CONTINUED WITH THE PROCEDURE ROBOTICALLY, NOTING THAT THEY ¿PLUGGED INTO A 3RD PARTY GENERATOR¿. THE PATIENT WAS DESCRIBED AS ¿STABLE, DOING GREAT¿. ON 02-JUL-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM AN ISI CLINICAL SALES REPRESENTATIVE (CSR), WHO SPOKE DIRECTLY WITH THE SURGEON, REGARDING THE REPORTED EVENT: PRIOR TO BEGINNING THE PROCEDURE, ONE ¿ROBOTIC PORT¿ AND ONE ¿LAP ASSIST PORT¿ HAD BEEN PLACED AND TWO MORE ROBOTIC PORTS NEEDED PLACEMENT, AN UNSPECIFIED THIRD PARTY LAPAROSCOPIC (LAP) SCISSORS INSTRUMENT ARCED WHEN THE LAP SCISSORS INSTRUMENT TIP TOUCHED THE METAL CANNULA OF THE ROBOTIC PORT SITE DURING THE ¿NON-ROBOTIC LYSIS OF ADHESIONS PORTION OF THE CASE¿. THIS RESULTED IN A ¿SLIGHT MARK; LIKE A SLIGHT BURN¿ ON PERITONEAL TISSUE NEAR THE ROBOTIC PORT SITE WHICH WAS SLIGHTLY WHITE IN APPEARANCE AND THE SIZE OF A PIN MARK, DESCRIBED AS LESS THAN A ONE-DEGREE BURN. NO MEDICAL INTERVENTION WAS REQUIRED. THE SURGEON HAD NOT STARTED THE ROBOTIC PORTION OF THE CASE AND HAD NOT GONE INTO FOLLOWING MODE. RATHER, THE SURGEON WAS ¿FINISHING THE NON-ROBOTIC LYSIS OF ADHESION PORTION BEFORE FINISHING ROBOTIC PORT PLACEMENT¿ WHEN THE SURGEON SAID THAT THE THIRD-PARTY LAP SCISSORS INSTRUMENT ARCED; THERE WAS A VISIBLE SPARK WHEN THE LAP SCISSORS INSTRUMENT TIP TOUCHED THE METAL CANNULA OF THE ROBOTIC PORT SITE. AN ENDOSCOPE AND THE PATIENT¿S PERITONEAL TISSUE WERE IN CLOSE PROXIMITY TO THE CANNULA AND THE LAP SCISSORS INSTRUMENT WHEN THE SPARK WAS OBSERVED. THE NON-ROBOTIC LYSIS OF ADHESION PORTION OF THE PROCEDURE COMPLETED WITH USE OF THE SAME LAPAROSCOPIC SCISSORS INSTRUMENT AND A THIRD-PARTY COVIDIEN GENERATOR; IT WAS UNKNOWN WHY THE SURGEON OPTED TO SWITCH TO A THIRD-PARTY GENERATOR. THERE WAS NO VISIBLE THERMAL DAMAGE TO ANY INSTRUMENTS OR ACCESSORIES. THEREAFTER, AND UPON PLACEMENT OF THE REMAINING TWO DA VINCI PORTS, THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE COMMENCED WITH USE OF THE ERBE GENERATOR. A GROUNDING PAD WAS IN USE AND WAS REPORTED AS PROPERLY PLACED ON THE PATIENT. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS AND NO INSTRUMENT ARCING DURING THE DA VINCI-ASSISTED PROCEDURE; THE ERBE GENERATOR WAS UTILIZED THROUGHOUT THE ENTIRE PROCEDURE WITHOUT ANY ISSUES. THE PROCEDURE COMPLETED AS PLANNED ROBOTICALLY WITH NO PATIENT INJURY. THERE WAS NO ALLEGATION OF A DA VINCI PRODUCT MALFUNCTION. ALL DA VINCI PRODUCTS WORKED AS EXPECTED AND AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750104 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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