BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19663069 · Received July 3, 2024

    Report

    Report Number
    2955842-2024-16529
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 10, 2024
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. IMAGES ASSOCIATED WITH THIS REPORTED EVENT WERE SUBMITTED FOR REVIEW. A REVIEW OF THE PROVIDED IMAGES WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT APPEARS THAT THE GRAY PLASTIC MOLDED INSULATOR HAS BROKEN, CAUSING THE ELECTRODE (GRIP PORTION) TO GET DISLODGED FROM THE GRIP BASE. THE METAL COMPONENTS LOOK INTACT, AND IT IS NOT CLEAR WHETHER THERE WERE ANY FRAGMENTS MISSING FROM THE MOLDED INSULATOR.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER-REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE BROKEN BOTH GRIP TIPS: ONE WAS COMPLETELY DETACHED FROM ITS BASE AND WAS NOT RETURNED WITH THE INSTRUMENT, AND THE OTHER WAS ONLY HELD BY THE CONDUCTOR WIRE AND HANGING FROM THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN GRIP SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING OR MISUSE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT TIP WAS DAMAGED. THE USER WAS COMPLETING THE PROCEDURE AS PLANNED USING A BACKUP FORCE BIPOLAR WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684419 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K10230219 0032 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.