BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23263372 · Received October 10, 2025

    Report

    Report Number
    2955842-2025-41258
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 15, 2025
    Report Date
    January 4, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE VESSEL SEALER INSTRUMENT; HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    THE VESSEL SEALER EXTEND INSTRUMENT HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE DISLODGED CONDUCTOR WIRE AT THE DISTAL END. THE WIRE WAS LOOSELY HANGING BUT NOT BROKEN. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST UPON TESTING. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO DAMAGE THROUGH EXTERNAL COLLISIONS OR DURING USE. A BROKEN CONNECTOR PIN OR RETENTION ISSUES CAN LEAD TO A DISLODGED CONDUCTOR WIRE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED A WIRE BECAME LOOSE AT THE TIP OF THE VESSEL SEALER EXTEND INSTRUMENT FOR NO APPARENT REASON. IT WAS STILL USABLE BUT WAS REPLACED FOR SAFETY REASONS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY. THE SURGICAL TASK BEING PERFORMED WHEN THE ISSUE OCCURRED WAS THE PREPARATION OF THE TISSUE. ISSUES RELATED TO THE OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT MOTION OF THE GRIPS, AND UP/DOWN MOTION OF THE WRIST COULD NOT BE ANSWERED AS THE INSTRUMENT WAS REPLACED FAIRLY DIRECTLY. THERE WAS A CABLE VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT, AS FAR AS REMEMBERED, ONE CABLE. THE COLOR OF THE BROKEN/LOOSE CABLE COULD NOT BE ANSWERED AS NO PHOTOS WERE TAKEN, BUT IT WAS MENTIONED THAT IT WAS A SILVER WIRE THAT LOOKED TORN OFF. THERE WAS NO LOSS OF CAUTERY ASSOCIATED WITH THE BROKEN/LOOSE CABLE, AND NO SIGNS OF THERMAL DAMAGE AT THE SITE OF BREAKAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE, AND NO DAMAGE RESULTED IN A FRAGMENT FALLING INSIDE THE PATIENT¿S ANATOMY. THE INSTRUMENT WAS AVAILABLE FOR RETURN TO ISI FOR EVALUATION AND HAD ALREADY BEEN SENT. NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR A VIDEO RECORDING OF THE PROCEDURE WAS AVAILABLE FOR ISI REVIEW, AND THE SEQUENCE NUMBER WAS SPECIFIED WHEN THE COMPLAINT WAS MADE BUT NOT NOTED HERE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317267 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-03 K15250404 0257 10886874115661

    Patients

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