BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 14724622 · Received June 16, 2022

    Report

    Report Number
    2955842-2022-12201
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 17, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED ERROR FAULT WAS REPRODUCED DURING FIELD EVALUATION AND CONFIRMED THROUGH REVIEW OF THE SITE¿S SYSTEM LOGS. INVESTIGATION INDICATED A DEFECTIVE MASTER TOOL MANIPULATOR (MTM) AXIS 1. REPLACEMENT OF THE RIGHT MTM ARM RESOLVED THE ISSUE. ADDITIONALLY, PROACTIVE REPLACEMENT OF THE MTM GIMBAL GRIP PADS DUE TO EXPECTED WEAR AND TEAR WAS PERFORMED. THE REPLACED MTM GIMBAL GRIP PADS ARE FIELD SCRAP ITEMS AND WILL NOT BE RETURNING TO ISI FOR FURTHER INVESTIGATION. FOLLOWING PART REPLACEMENT, THE SYSTEM WAS FURTHER TESTED, OPERATED WITHOUT ERROR AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REPLACED MTM ARM INVOLVED WITH THIS COMPLAINT. HOWEVER; DEVICE EVALUATION REMAINS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE FAILURE ANALYSIS HAS BEEN COMPLETED OR ADDITIONAL INFORMATION HAS BEEN RECEIVED. VERIFICATION VIA LOGS CONFIRMS THE OCCURRENCE OF THE ERROR FAULT A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM SH1834 MATCHING THE DOCUMENTED EVENT DETAILS. THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE PROCEDURE WAS STARTED IN DUAL SURGEON CONSOLE SETUP; HOWEVER, AN ISSUE PROMPTED THE USER TO DISABLE ONE OF THE SURGEON CONSOLES TO CONTINUE THE PROCEDURE. SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS H4 & H7 ARE NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3 FAILURE ANALYSIS INVESTIGATION CAN BE FOUND IN THE FOLLOWING FIELDS: H6 AND H10 INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. DURING FAILURE ANALYSIS, THE MTM WAS TESTED (SINE CYCLE) AND FAILED WITH ERROR CODE 23025 ALONG AXIS 1. INDICATIVE OF A FAULTY AXIS 1 MOTOR AND AXIS 1 MOTOR CABLE. A COMPONENT FAILURE WAS DETERMINED TO BE THE ROOT CAUSE OF THE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE USING A DUAL SURGEON CONSOLE (SC) SETUP, THE SYSTEM DISPLAYED INFORMATIONAL CODE 23025 ON THE RIGHT MASTER TOOL MANIPULATOR (MTM) ARM OF SC1. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). PRIOR TO THE CALL, USER DISABLED SC1. REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRMED THE OCCURRENCE OF INFORMATIONAL ERROR CODE 23025 AND 23015 ON SC1 RIGHT MTM AXIS 1. AS THE USER ALREADY DISABLED ONE OF THE SC. NO FURTHER TROUBLESHOOTING WAS PERFORMED. NO FURTHER ISSUE WAS CONFIRMED. THE USER CONTINUED WITH THE PROCEDURE USING SURGEON CONSOLE 2 (SC2). NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ISI FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE SITE'S MEDICAL ENGINEER REGARDING THE REPORTED EVENT: THE SYSTEM FUNCTIONALITY WAS CHECKED PRIOR TO STARTING THE PROCEDURE AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERROR.

    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
    162224 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-11 N/A 00886874110874

    Patients

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