BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22384906 · Received July 2, 2025

    Report

    Report Number
    2955842-2025-28557
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 4, 2025
    Report Date
    June 4, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THE FORCE BIPOLAR INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE WITHIN THE BIPOLAR YAW PULLEY, BETWEEN THE WIRE CRIMP THE GRIP AND THE SILICONE POTTING, WHICH SEALS THE WIRE ENTRANCE TO THE YAW PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT. COMPONENTS ADJACENT TO THE BROKEN DO NOT SHOW DAMAGE. THE PROBABLE ROOT CAUSE OF THE INSTRUMENT BECOMING STUCK IN ARM 1 MAY BE DUE TO MECHANICAL DAMAGE TO THE INSTRUMENT TIP, WHICH COULD HAVE HINDERED ITS PROPER RETRACTION THROUGH THE PORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WAS STUCK ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) ARM 1. NO ERROR RELATED TO ARM 1 WAS FOUND IN LOGS. THE SITE INDICATED THAT THE INSTRUMENT WAS BROKEN AT THE TIP, SO THEY WERE NOT ABLE TO REMOVE IT THROUGH THE PORT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE SITE TO REMOVE THE INSTRUMENT FROM ARM 1. 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 SITE WAS ABLE TO REMOVE THE INSTRUMENT USING THE PORT CLUTCH WITHOUT INCREASING THE PORT INCISION. COMPLAINT ALLEGES THAT THE FORCE BIPOLAR INSTRUMENT WAS REMOVED WITH THE CANNULA DUE TO JAW MISALIGNMENT. IT IS CURRENTLY UNKNOWN IF THE JAWS WERE DISLODGED. THE INSTRUMENT JAWS WERE STUCK IN A CLOSED POSITION BUT WERE NOT STUCK ON THE TISSUE AT THE TIME OF THE EVENT. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING PROCEDURE. THERE WAS NO REPORT OF FRAGMENT FALLING INSIDE THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170439 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10250304 0329 00886874120767

    Patients

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