BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17374902 · Received July 21, 2023

    Report

    Report Number
    2955842-2023-17224
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 22, 2023
    Report Date
    June 22, 2023
    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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE PERMANENT CAUTERY HOOK INSTRUMENT WAS BURNED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION WAS PERFORMED, AND THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE AT THE WELD ON THE MONOPOLAR YAW PULLEY. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. ADDITIONAL OBSERVATIONS RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE WELD. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE CONDUCTOR WIRE CAP. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE AT THE WELD ON THE DISTAL CLEVIS. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE FROM THE WELD ON THE DISTAL IDLER PULLEYS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN DISTAL CLEVIS OPPOSITE THE SIDE OF THE WELD. THE BROKEN PIECE MEASURING APPROXIMATELY 0.234" X 0.175", IN SIZE WAS NOT RETURNED WITH THE INSTRUMENT. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS BURNED AT THE END. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569194 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-16 K10230108 0100 00886874112311

    Patients

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