BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 25166992 · Received May 14, 2026

    Report

    Report Number
    2955842-2026-24853
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 13, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM PROGRASP FORCEPS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS INSTALLED AND OPERATED ON AN IN-HOUSE SYSTEM. IT PASSED RECOGNITION AND ENGAGEMENT TESTING, DEMONSTRATED FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE GRIP TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT ALSO PASSED THE GRIP TEST AND BUMPER TEST, AND THE REPORTED GRIP BACKLASH IS AN EXPECTED DESIGN CHARACTERISTIC AND IS WITHIN SPECIFICATION. THE INSTRUMENT WAS RECOGNIZED BY THE TEST SYSTEM AND PASSED ALL FUNCTIONAL TESTING. NO PRODUCT ISSUE WAS IDENTIFIED, AND THE INSTRUMENT WAS DETERMINED TO BE FULLY FUNCTIONAL. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO ABNORMALITIES NOTED WITH THE INSTRUMENT. THERE WAS NO KEY OR MECHANISM USED. THERE WAS NO OTHER INSTRUMENT USED TO PRY OPEN JAWS. THE JAWS WERE NOT STUCK ON THE TISSUE WHEN THE ISSUE OCCURRED. THERE WAS NO ADVERSE EFFECT TO ANY GRASPED TISSUE. NO UNEXPECTED TISSUE REMOVAL WAS NOTICED. THERE WAS NO BLEEDING OBSERVED DUE TO UNCLAMPING TISSUES. THE INSTRUMENT DID NOT HAVE UNCONTROLLED MOTION. THE MOVEMENTS OF THE SURGEON DID NOT SCALE APPROPRIATELY TO THE INSTRUMENT. THE INSTRUMENT DID NOT MOVE WITH DELAY. THE INSTRUMENT WAS NO SHAKY OR HAD ANY FRICTION. THE SURGEON'S HEAD WAS INSIDE THE SURGEON SIDE CONSOLE, AND THE SURGEON HAD NOT REMOVED THEIR HANDS FROM THE HAND CONTROLS WHEN THE ISSUE OCCURRED. THE CUSTOMER USED A BACKUP INSTRUMENT.

    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

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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 WHEN TRYING TO OPEN OR CLOSE JAW, THE WRIST BENDS. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448268 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-14 K10250424 0353 00886874119785

    Patients

    Seq Age Sex Outcome Treatment
    1