BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 24834913 · Received April 9, 2026

    Report

    Report Number
    2955842-2026-20925
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    October 29, 2025
    Report Date
    April 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED WRIST CABLE IN THE PROXIMAL AREA. THE HOUSING WAS REMOVED, AND A CABLE WAS FOUND TO BE DISLODGED FROM THE CLAMPING PULLEY WHERE THE JOGGLE UP/DOWN IS ARTICULATED. THE CABLES WERE INSPECTED AND FOUND TO HAVE NO DAMAGE. DUE TO THE DISLODGED CABLE, THE INSTRUMENT WAS OBSERVED TO HAVE IMPRECISE MOTION. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT. THE ENERGY DELIVERY WAS TESTED AND PASSED. ADDITIONALLY, THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND DRIVEN. THE INSTRUMENT EXHIBITED IMPRECISE MOTION IN THE JOGGLE UP/DOWN DIRECTION DUE TO THE DISLODGED CABLE INSIDE THE HOUSING. THE GRIP TIPS MOVED IN THE DIRECTION COMMANDED, A LAG OR DELAY IN THE MOTION WAS OBSERVED. THE INSTRUMENT'S CONDUCTOR WIRE WAS FOUND TO HAVE A HERNIATION AT THE CLEVIS. THE CABLE APPEARS TO BE PROTRUDING WHEN THE GRIP IS CLOSED. FURTHERMORE, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CHASSIS INSIDE THE HOUSING. ONE OF THE MID CHASSIS TABS APPEARS TO BE BROKEN. THE BROKEN PIECE WAS RETURNED, MEASURING ROUGHLY 4MM IN SIZE. ALSO, THE INSTRUMENT WAS FOUND TO HAVE HAIRLINE CRACKS ON THE GRIP INPUT. THE HAIRLINE CRACK MEASURED AROUND 2.52 MM IN LENGTH. FURTHERMORE, THE INSTRUMENT WAS FOUND TO HAVE CORRODED BEARINGS. THE HOUSING WAS REMOVED, AND TEN BEARINGS INSIDE SHOWED CORROSION. 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. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT MOVING EFFECTIVELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133348 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10220214 0014 00886874114339

    Patients

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