BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20950088 · Received December 17, 2024

    Report

    Report Number
    2955842-2024-23329
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 22, 2024
    Report Date
    November 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEYS. THE CABLE WAS FULLY BROKEN. AS A RESULT OF THE FULL BREAK, FUNCTIONAL TESTING FOR MOTION RELATED ISSUES COULD NOT BE PERFORMED. THERE WAS NO DISCOLORATION, CORROSION, OR CONTAMINATION ON THE CABLE THAT WOULD OCCUR FROM IMPROPER FLUSHING OR RINSING DURING REPROCESSING. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE COMPLAINT REGARDING A BROKEN WIRE WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE MEGA NEEDLE DRIVER BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WIRE WAS BROKEN AT THE INSTRUMENT SHAFT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT DID NOT COLLIDE WITH AND OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO THE OPENING/CLOSING OF THE GRIPS, THE LEFT/RIGHT MOTION OF THE GRIPS, NOR THE UP/DOWN MOTION OF THE WRIST. THERE WAS ONE VISIBLY PROTRUDING CABLE IDENTIFIED AT THE DISTAL END OF THE INSTRUMENT. IT WAS UNKNOWN IF THE CABLE WAS RELATED TO THE OPENING/CLOSING OF THE JAWS OR THE UP/DOWN MOTION OF THE WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720945 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K10240523 0351

    Patients

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