BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 15612767 · Received October 16, 2022

    Report

    Report Number
    2955842-2022-14132
    Event Type
    Malfunction
    Date Received
    October 16, 2022
    Date of Event
    August 22, 2022
    Report Date
    August 23, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED ISSUE WAS NOT REPRODUCED. THE SYSTEM PASSED ALL REQUIRED TESTS AND SEVERAL GUIDED TOOL CHANGE ON USM 4 WERE PERFORMED WITHOUT ANY ISSUE OBSERVED. THERE WERE NO PART REPLACEMENT REQUIRED. UNRELATED TO THE ISSUE, FSE UPGRADED THE SYSTEM SOFTWARE. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. PROCEDURE LOG REVIEW CONFIRMED THE OCCURRENCE OF A RADICAL PROSTATECTOMY PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6)2022 USING SYSTEM (B)(4) MATCHING THE DOCUMENTED EVENT DETAILS. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: ALTHOUGH THE FSE CONFIRMED THAT THE SURGEON WAS STILL IN FOLLOWING MODE WHEN THE ENERGY CABLE WAS RECONNECTED AND FORCE WAS APPLIED TO THE TOP OF THE INSTRUMENT, THE CUSTOMER ALLEGED THAT THE GUIDED TOOL CHANGE DID NOT WORK, AND CAUSED THE MONOPOLAR CURVED SCISSORS INSTRUMENT TO GO DEEPER THAN EXPECTED. SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LEAD TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Additional Manufacturer Narrative · 0

    REFER TO THE FOLLOWING SECTIONS FOR ADDITIONAL INFORMATION: G3, G6, H2, H10. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER ON (B)(6) 2022 AND (B)(6) 2022 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) RECEIVED A PHONE CALL FROM AN EXECUTIVE ASSISTANT AT THE HOSPITAL AND WAS INFORMED THAT THE ARM OF THE ROBOT HAD MOVED WITHOUT THE SURGEON TOUCHING IT AND THAT THE INSTRUMENT WENT IN THE RECTUM AREA. THE CSR LATER RECEIVED ANOTHER CALL FROM AN OPERATING ROOM (OR) STAFF MEMBER AND PROVIDED ANOTHER VERSION. THE OR STAFF INDICATED THE SURGEON REQUESTED TO CHANGE THE BIPOLAR INSTRUMENT WITH A NEEDLE HOLDER INSTRUMENT DURING AN ANASTOMOSIS. THE OR STAFF THEN REMOVED THE CABLE FROM THE INSTRUMENT, BUT THE SURGEON INDICATED HE WAS NOT FINISHED. WHEN THE OR STAFF PUT THE CABLE BACK ON, THEY PUSHED THE INSTRUMENT. HOWEVER, THE SURGEON DID NOT HAVE HIS HEAD IN THE CONSOLE. THE CSR NOTED THAT IT WAS UNCLEAR HOW THE SURGEON WAS ABLE TO SEE THE INSTRUMENT REPORTEDLY TOUCH THE RECTUM IF HIS HEAD WAS NOT IN THE CONSOLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY-SIMPLE SURGICAL PROCEDURE, THE OPERATING ROOM (OR) TEAM EXPERIENCED AN ISSUE WITH THE UNIVERSAL SURGICAL MANIPULATOR 4. THE CALLER (NURSE) INDICATED THAT THE GUIDED TOOL CHANGE DID NOT WORK WHEN THE OR STAFF REMOVED A NEEDLE DRIVER INSTRUMENT TO INSTALL A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE NURSE ALSO STATED THAT THE MCS HAD GONE APPROXIMATELY 3 CENTIMETER DEEPER AND TOUCHED THE RECTUM; WITHOUT HARM TO THE PATIENT. THE NURSE CONFIRMED THAT THE GUIDED TOOL CHANGE WAS NOT TESTED AT THE END OF SURGERY. INTUITIVE SURGICAL, INC. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM EVENT LOGS BUT COULD NOT SEE ANY RELEVANT ERROR OR INFORMATION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY AND NO DELAYS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH ISI FIELD SERVICE ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON ASKED FOR A TOOL EXCHANGE SO, THE PATIENT CART OPERATOR DISCONNECTED THE ENERGY CABLE ON THE INSTRUMENT. THE SURGEON THEN DECIDED NOT TO CHANGE THE INSTRUMENT. THE CART OPERATOR RECONNECTED THE ENERGY CABLE, WHEN SURGEON WAS IN FOLLOWING MODE, AND APPLIED FORCE TO THE TOP OF THE INSTRUMENT (WITHOUT HOLDING IT) WHICH PUSHED THE INSTRUMENT DOWN INSIDE THE PATIENT. THE SURGEON MANIPULATOR ALSO MOVED DOWN, FOLLOWING THE INSTRUMENT MOVEMENT. "FOLLOWING MODE¿ IS WHEN THE SURGEON HAS THEIR HEAD INSIDE THE SURGEON SIDE CONSOLE. IN THIS MODE, THE SURGEON CONSOLE MANIPULATORS AND THE PATIENT CART ARMS ARE FREE TO MOVE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665860 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-37 N/A 00886874110720

    Patients

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