BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 24450623 · Received February 25, 2026

    Report

    Report Number
    2955842-2026-04872
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 10, 2026
    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
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE ENDOSCOPE WAS ANALYZED AND 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. ADDITIONALLY, THE ENDOSCOPE WAS TESTED AND PLACED ON A CAMERA ATTENUATION TESTER TO MEASURE TRANSMITTANCE, BUT FAILED FUNCTIONAL TESTING. THE ENDOSCOPE FAILED TRANSMITTANCE DUE TO THE MEASURED OUTPUT POWER NOT MEETING SPECIFICATION LIMITS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF BINDING IN CAMERA INSTRUMENT ADAPTER IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. 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

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED BILATERAL INTERNAL MAMMARY ARTERY HARVEST SURGICAL PROCEDURE, SITE CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT ROTATION ISSUE WITH THE 30-DEGREE ENDOSCOPE PLUS. THE SITE COULD NOT USE IT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE LOGS SHOW THAT THE SCOPE WAS USED ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372361 NONE ENDOSCOPE PLUS NAY INTUITIVE SURGICAL, INC 470057-08 N/A 00886874116555

    Patients

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