BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17992350 · Received October 23, 2023

    Report

    Report Number
    2955842-2023-19519
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 25, 2023
    Report Date
    September 27, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119815
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF IMPRECISE MOTION TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO EXHIBIT IMPRECISE MOTION. THE INSTRUMENT WAS FOUND TO HAVE A LOOSE PITCH CABLE WHICH LED TO THE IMPRECISE PITCH MOTION. ADDITIONAL FINDINGS NOT REPORTED BY SITE WERE ALSO IDENTIFIED: THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS FOUND TO HAVE A LOOSE PITCH CABLE AT THE DISTAL END.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS DID NOT CONFIRM OR REPLICATE THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE A LOOSE PITCH CABLE ON THE PROXIMAL END. THE INSTRUMENT COULD NOT BE TESTED FOR INTUITIVE MOTION SINCE IT FAILED ENGAGEMENT ON THE IN-HOUSE SYSTEM. THE INSTRUMENT FAILED MECHANICAL ENGAGEMENT WHEN BEING TESTED. INSTRUMENT INPUTS FAILED TO ENGAGE WITH THE STERILE ADAPTER IN MULTIPLE ATTEMPTS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER COULD NOT BE MANIPULATED PROPERLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE A FOLLOW-UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS. THIS COMPLAINT WILL BE CLASSIFIED BASED ON THE PROVIDED INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158081 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230518 0400 00886874119815

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES