BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 22102184 · Received May 28, 2025

    Report

    Report Number
    2955842-2025-20996
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 1, 2025
    Report Date
    May 1, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874116562
    PMA / PMN Number
    K191736
    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

    THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND ERROR 23003 POINTING TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AXIS 4. THE ISSUE WAS RESOLVED BY CANCELING THE GUIDED TOOL CHANGE. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED. THE PROBABLE ROOT CAUSE WAS GUIDED TOOL CHANGE BEING ACTIVATED AT THAT TIME AND CANCELLING THIS WOULD RESOLVE THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AN ERROR OCCURRED AND IT HAD BEEN CLEARED BEFORE CONTACTING TECHNICAL SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND ERROR 23003 POINTING TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AXIS 4 AND EXPLAINED WHAT THE ERROR MEANING WITH THE CAMERA ARM (P11). THE CUSTOMER ACKNOWLEDGED IT. AFTER THAT, THE SURGEON WHO WAS AT THE PATIENT SIDE CART (PSC) SIDE ROTATED THE 0-DEGREE ENDOSCOPE TO 180 DEGREES, THEN THE SURGEON AT THE SURGEON SIDE CONSOLE (SSC) STATED THAT THE IMAGE AND THE USM MOVEMENTS FLIPPED 180 DEGREES. THE TSE EXPLAINED THAT IT WAS AN EXPECTED BEHAVIOR IF THE 0-DEGREE ENDOSCOPE WAS ROTATED 180 DEGREES FROM THE PSC SIDE. THE ISSUE WAS RESOLVED BY CANCELING THE GUIDED TOOL CHANGE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE IMAGE WAS INVERTED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709746 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-11 N/A 00886874116562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES