BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22553537 · Received July 21, 2025

    Report

    Report Number
    2955842-2025-30445
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 26, 2025
    Report Date
    June 27, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT ASSOCIATED WITH THIS COMPLAINT. FAILURE ANALYSIS DID NOT CONFIRM THE REPORTED EVENT. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM, SHOWING THREE LIVES REMAINING. THE INSTRUMENT PASSED GRASPING, RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THERE WAS NO PHYSICAL DAMAGE. THE INSTRUMENT WAS FULLY FUNCTIONAL. THERE WAS NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT KEPT GETTING TISSUE, INCLUDING THE BOWEL, STUCK WITHIN THE GEARS; THE SURGEON NOTED DIFFICULTY REMOVING THE TISSUE. THE INSTRUMENT WAS PULLING TISSUE INTO THE GEARS, PROMPTING DISCONTINUATION OF USE; NO TISSUE WAS EXCISED, NO REMOVAL ISSUES OCCURRED, AND NO MEDIA IS AVAILABLE. A BACKUP INSTRUMENT WAS UTILIZED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1738114 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K16250206 0197 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES