BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23690129 · Received December 2, 2025

    Report

    Report Number
    2955842-2025-47108
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 21, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE 8MM PROGRASP FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO BE FUNCTIONAL. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. IT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP TIPS OPENED AND CLOSED PROPERLY. ADDITIONAL OBSERVATION(S) : THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MAIN TUBE. THE DAMAGE WAS LOCATED WHERE THE MAIN TUBE AND DISTAL END MEET. THE PROGRASP FORCEPS INSTRUMENT DOES NOT HAVE A CONDUCTOR WIRE NOR RELEASES ENERGY. A REVIEW OF THE SYSTEM LOGS INDICATED THAT AN 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS USED WITH THE NON-ENERGY INSTRUMENT. THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE PROBABLE ROOT CAUSE OF THERMAL DAMAGE ON MAIN TUBE OF NON-ENERGY INSTRUMENT IS TYPICALLY ATTRIBUTED TO THE USER. THIS MAY RESULT FROM INADVERTENT COLLISIONS BETWEEN THE TWO INSTRUMENTS. THERMAL ENERGY WAS CONDUCTED ON THE MAIN TUBE, RESULTING IN VISIBLE THERMAL DAMAGE.

    Additional Manufacturer Narrative · 0

    THE QUALITY ENGINEERING (QE) TEAM OF INTUITIVE SURGICAL INC., (ISI) RE-EVALUATED THE COMPLAINT. FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED : WHEN MONOPOLAR/BIPOLAR ENERGY INSTRUMENTS ARE USED IN PROXIMITY TO NON-ENERGY INSTRUMENTS, POTENTIAL ARCING CAN OCCUR, WHICH MAY LEAD TO DAMAGE TO ADJACENT INSTRUMENTS. WHILE THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED SINCE THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS, THE THERMAL DAMAGE OBSERVED ON THE PROGRASP FORCEPS INSTRUMENT MAY HAVE BEEN CAUSED BY INADVERTENT COLLISIONS BETWEEN THESE TWO INSTRUMENTS, RESULTING IN VISIBLE THERMAL DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PROGRASP FORCEPS INSTRUMENT WAS NOT WORKING CORRECTLY. IT MOVED IN ONE DIRECTION BUT DID NOT MOVE IN OTHER DIRECTION. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783203 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K11250821 0539 00886874112298

    Patients

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