BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 18493116 · Received January 11, 2024

    Report

    Report Number
    2955842-2024-10170
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 15, 2023
    Report Date
    December 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE PERSONALITY MODULE VISION ACQUISITION (PMVA) WAS ANALYZED, AND FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE PMVA WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED WITH ERROR 17 AT START-UP. FA WAS NOT ABLE TO TEST VIDEO OUTPUT, BECAUSE THE DIGITAL VIDEO INTERFACE (DVI) OUTPUT WAS DAMAGED AND HAD BENT PINS. THE HOUSING HAS OXIDIZED. THE DUAL CAMERA CCU (DOCO) WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THERE WAS AN ERROR 17 IN THE SYSTEM LOGS. THE DOCO WAS INSTALLED ON THE PRINTED CIRCUIT ASSEMBLY (PCA) SI SYSTEM AND IT POWERED UP NORMALLY WITH NO ERROR. IT PASSED THE COMMUNICATION, WHITE BALANCE, AND CALIBRATION TESTS. THERE WAS GOOD VIDEO IN BOTH EYES AND WENT THROUGH TEN POWER CYCLES WITH NO ISSUE. THIS PART HAD NO TROUBLE FOUND.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE COULD NOT REPRODUCE THE ERROR. THE FSE REPLACED THE DUAL CAMERA CONTROL UNIT (DOCO), PERSONALITY MODULE VISION ACQUISITION (PMVA), AND THEIR JUNCTION CABLE DUE TO THE NON-RECOVERABLE ERRORS 17 AND 32 DURING THE SURGERY. AFTER DISCUSSING THE ISSUE WITH THE SURGEONS, THE ERRORS MIGHT HAVE BEEN LINKED TO THE FORCEFX ELECTROSURGICAL UNIT (ESU). IF THE ERROR COMES BACK, THE FSE ASKED THE CUSTOMER TO CHANGE THE POWER PLUG WALL FOR THE ESU, REPLACE THE INSTRUMENT ENERGY CORDS, REPLACE THE ESU, AND REPLACE THE PERSONALITY MODULE ENERGY DEVICE (PMED) CABLE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. .

    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 RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THEY WERE FACING A REPEATED NON-RECOVERABLE 17 FAULT. PRIOR TO THE CALL, THE CUSTOMER HAD ALREADY POWER CYCLED THE SYSTEM, WHICH SHOWED NO IMPROVEMENT. THE TSE CHECKED THE LIVE LOGS AND FOUND ERRORS 17 AND 32 POINTING TO AN ISSUE ON THE DUAL CAMERA CONTROL UNIT (DOCO). THE TSE ASKED THE CUSTOMER TO PERFORM A HARD POWER CYCLE WITH THE BREAKERS ON THE VISION SIDE CART (VSC) BUT THE ERRORS REOCCURRED. THE TSE GUIDED THE CUSTOMER TO CHECK CONNECTIONS BETWEEN THE DOCO AND PERSONALITY MODULE VISION ACQUISITION (PMVA) TO MAKE SURE EVERYTHING WAS PROPERLY CONNECTED. THE TSE ASKED THE CUSTOMER TO CHECK IF THE LED INDICATOR WAS BLUE ON THE DOCO, WHICH WAS THE CASE. THE TSE REQUESTED THE CUSTOMER TO SWITCH THE BREAKER OFF ON THE VSC, ILLUMINATOR, DOCO AND CORE. THE TSE ALSO REQUESTED THE CUSTOMER TO RESTART THE SYSTEM, BUT THE CUSTOMER STATED THAT THE ERROR REAPPEARED AGAIN. THE PROCEDURE WAS ABORTED POST-ANESTHESIA AND PORT PLACEMENT AND POSTPONED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. THE CUSTOMER CONFIRMED THAT THERE WERE NO ISSUES NOTED DURING THE SETUP OF THE SYSTEM. THE CUSTOMER CONFIRMED THAT THE PATIENT TOLERATED THE CHANGE WITH NO CONSEQUENCES. THERE WERE NO AFTER-EFFECTS PRESENT. THE PATIENT DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS FOLLOWING THE CANCELLATION OF THE SURGICAL PROCEDURE POST-PORT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002494 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-12 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES