BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24613018 · Received March 16, 2026

    Report

    Report Number
    2955842-2026-16189
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 16, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS REPORT OF FRAYED CABLES AT THE WRIST. THE PHYSICAL DAMAGE WAS LOCATED NEAR THE USEFUL END OF THE INSTRUMENT THAT ENTERS THE PATIENT¿S BODY. NO MATERIAL MISSING OR DETACHED FROM THE PORTION OF THE DEVICE THAT ENTERS THE PATIENT¿S BODY. FRAYING WAS NOTICED PRIOR TO NEXT USE. THE INSTRUMENT HAS NOT BEEN SHIPPED BACK TO ISI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621545 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-14 NA

    Patients

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