BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22243564 · Received June 17, 2025

    Report

    Report Number
    2955842-2025-25616
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    April 11, 2025
    Report Date
    June 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE WELD ON YAW PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED, AND ADDITIONAL INFORMATION WAS RECEIVED: THE CUSTOMER PROVIDED AN IMAGE OF THE INSTRUMENT; HOWEVER, THE POTENTIAL ISSUE / DAMAGE COULD NOT BE SEEN NOR DETERMINED BASED ON THE IMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT DID NOT CAUTERIZE/INSUFFICIENT ENERGY. THERE WERE DIFFICULTIES WITHIN WRIST/ENERGY USING THE INSTRUMENT. 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 INSTRUMENT WAS NOT WORKING WHEN THE SURGEON WAS ABOUT TO USE IT DURING THE PROCEDURE. THEY DID NOT OBSERVE ANY PHYSICAL DAMAGE OR BROKEN CABLES, SO IT COULD BE RELATED MORE WITH ENERGY, HOWEVER IT COULD ALSO BE A MISTAKE DURING THE INSTRUMENT PREPARATION AND THAT IT COULD HAVE NO DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630121 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-18 K17241212 0101 00886874112311

    Patients

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