BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24559364 · Received March 10, 2026

    Report

    Report Number
    2955842-2026-15165
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 5, 2026
    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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ENDOSCOPES MOVED FREELY WITH UNCONTROLLED MOTION. THE SETTINGS WERE CORRECT, HOWEVER, THE IMAGE AND THE CAMERA MOTION WERE INVERTED. THERE WAS NO APPARENT DAMAGE ON THE ENDOSCOPE'S BASE. THE ENDOSCOPE WAS NOT ROTATED MANUALLY 180 DEGREES PRIOR TO THE EVENT. THE SURGEON HAD NOT MANUALLY ASSOCIATED THE RIGHT AND THE LEFT CONTROLS WITH THEIR RESPECTIVE ARMS FOR INTUITIVE MOTION. THERE WAS NO PATIENT INJURY. THE ARMS WORKED WELL ONCE THE ENDOSCOPES WERE SWITCHED OUT. THE SITE HAS RETURNED THE ENDOSCOPE. THERE ARE NO PHOTOS OR VIDEOS FOR ISI REVIEW.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR FOR FAILURE ANALYSIS INVESTIGATION. THE USM WAS ANALYZED AND FOUND TO HAVE NO FUNCTIONAL ISSUES WHEN INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED ALL RELEVANT TESTING ON A TEST FIXTURE. THE 0 DEGREE ENDOSCOPE THAT WAS USED AT THE BEGINNING OF THE PROCEDURE WAS RETURNED. THIS ENDOSCOPE WAS FOUND TO HAVE A CAMERA INSTRUMENT ADAPTER DEFECT, THAT WOULD BE RELATED TO THE CUSTOMER REPORTED ISSUE. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER WAS REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH THE SHAFT BEARING CONTRIBUTING TO FRICTION. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. BLANK MDR FIELDS: 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 G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE USING AN XI SYSTEM, THE IMAGE WAS INVERTED WHILE USING A 0-DEGREE ENDOSCOPE INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 2. THE ISSUE WAS REPORTED TO TECHNICAL SUPPORT AFTER COMPLETING THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) NOTED ENGAGEMENT ERRORS 22020 ON ARM 2. THE CUSTOMER RESEATED THE ENDOSCOPE, AND UPON REINSTALLATION, THEY HEARD A STRANGE NOISE, AND THE ENDOSCOPE DID NOT ROTATE PROPERLY. THE CUSTOMER REPLACED THE ENDOSCOPE, WHICH CORRECTED THE INVERTED IMAGE, BUT THEN THE SURGEON'S HAND CONTROLS OPERATED THE OPPOSITE ARMS, EVEN THOUGH THE ASSIGNMENTS WERE SET CORRECTLY. THE CUSTOMER RESEATED THE BACKUP ENDOSCOPE, WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328511 NONE ENDOSCOPE NAY INTUITIVE SURGICAL, INC 470056-12 N/A 00886874116562

    Patients

    Seq Age Sex Outcome Treatment
    1