BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25055952 · Received May 1, 2026

    Report

    Report Number
    2955842-2026-23207
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 1, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE 8MM PROGRASP FORCEPS INSTRUMENT CAN NO LONGER BE FULLY OPENED. 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 SURGEON FELT THAT THE INSTRUMENT COULD NOT BE OPENED PROPERLY WHILE IT WAS FREE WITHIN THE ABDOMEN, AND AT THAT TIME, IT WAS NOT GRASPING ANY TISSUE OR OTHER MATERIAL. THE INSTRUMENT WAS REMOVED IN THE STANDARD MANNER, WITHOUT THE USE OF FORCE TO OPEN IT, A KEY, OR ANY OTHER MEANS. A NEW ONE WAS USED. THE JAWS WERE NOT CLAMPED ON THE TISSUE WHEN THE EVENT OCCURRED. THERE WAS NO ADVERSE EFFECT TO THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212974 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K12240627 0114 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1