BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22057615 · Received May 20, 2025

    Report

    Report Number
    2955842-2025-20549
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 25, 2025
    Report Date
    April 25, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116555
    PMA / PMN Number
    K191736
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE CUSTOMER PERFORMED A HARD POWER CYCLE AND COMPLETED ANOTHER CASE WITHOUT ISSUE BEFORE THE FSE ARRIVED. THE FSE PUT THE ENDOSCOPE ON SEVERAL UNIVERSAL SURGICAL MANIPULATORS (USM) AND TEST DROVE ON EACH ONE. FSE CYCLED THROUGH UP/DOWN VIEWS ON THE SURGEON SIDE CONSOLE (SSC) TOUCHSCREEN. FSE REMOVED AND REINSTALLED THE CAMERA SEVERAL TIMES IN EACH USM AND FOUND NO ISSUES. FSE WAS NOT ABLE TO REPRODUCE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FSE'S FIELD EVALUATION. FSE WAS UNABLE TO REPRODUCE THE ISSUE. THE FSE'S SERVICE VISIT DID NOT REVEAL ANY ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THAT THE CAMERA IMAGE WAS UPSIDE DOWN AND CAMERA ARM MOVED WHEN INSTALLING INSTRUMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM3). THE CALLER WAS NOT IN THE ROOM AT THE TIME OF ISSUE AND WAS NOT WILLING TO ASK THE SURGEON QUESTIONS WHILE IN PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGICAL TASK BEING PERFORMED AT THE TIME OF EVENT WAS XI ROBOT LAPAROSCOPIC CHOLECYSTECTOMY. TH IMAGE WAS INVERTED. THE ENDOSCOPE DID NOT MOVE FREELY WITH UNCONTROLLED MOTION. CONTACT PERSON WAS NOT SURE IF THE EVENT INVOLVED A REVERSED CONTROL ON SYSTEM ARMS. IT WAS A 30-DEGREE ENDOSCOPE INSTALLED AT THE TIME OF EVENT. CONTACT PERSON STATED THEY WERE UNSURE OF IF 30-DEGREE ENDOSCOPE WAS IN USE, AND IF IT WAS INSTALLED IN UP OR DOWN ORIENTATION. THE SURGEON STATED IT WAS INSTALLED CORRECTLY. THE SURGEON CONFIRMED DESIRED ORIENTATION WHEN THE ENDOSCOPE WAS INSTALLED. CONTACT PERSON WAS NOT SURE IF AN INDICATION OF THE IMAGE ORIENTATION PROVIDED TO THE USER VIA USER INTERFACE. THE ENDOSCOPE AND ENDOSCOPE¿S ADAPTER/BASE WERE STILL ENGAGED/IN-SYNCH/ATTACHED. THERE WAS NO DAMAGE OBSERVED ON THE ENDOSCOPE¿S ADAPTER/BASE SUCH AS MISSING SCREW(S) OR COMPONENT. CONTACT PERSON WAS NOT SURE IF THE ENDOSCOPE MANUALLY ROTATED 180 DEGREES. CONTACT PERSON WAS NOT SURE IF THE SURGEON MANUALLY ASSOCIATED THE RIGHT AND LEFT MASTERS WITH THE RESPECTIVE ARMS FOR INTUITIVE MOTION. THE ISSUE WAS RESOLVED BY THE ROBOT FINALLY ORIENTED IN THE CORRECT POSITION. PROCEDURE WAS COMPLETED WITH THE ENDOSCOPE WHEN THE ROBOT STARTED TO WORK PROPERLY. THE VISION ISSUE DID NOT RESULT IN PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71842 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES