BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20048222 · Received August 23, 2024

    Report

    Report Number
    2955842-2024-18540
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    July 29, 2024
    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
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEY. THE CABLE WAS FULLY BROKEN. 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 MAY CONTRIBUTE. THE COMPLAINT WAS CONFIRMED BY 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 CABLE BROKE WHILE SURGEON WAS SUTURING. INSTRUMENT WAS HANDED OFF AND A DIFFERENT MEGA SUTURECUT NEEDLE DRIVER WAS GIVEN TO SURGEON TO FINISH CASE. 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 INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE SURGICAL TASK BEING PERFORMED WHEN THE ISSUE OCCURRED WAS SUTURING OF MESH. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THERE WERE NO ISSUES RELATED TO OPENING/CLOSING OF THE GRIPS. THERE WERE NO ISSUES RELATED TO LEFT/RIGHT (YAW) MOTION OF THE GRIPS. THE ISSUE WAS NOT RELATED TO UP/DOWN (PITCH) MOTION OF THE WRIST. THERE WERE NO CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. THE PROTRUDING CABLE(S) WAS THE ONE(S) THAT CONTROLS OPENING/CLOSING OF THE JAWS. THE PROTRUDING CABLE(S) ONE(S) THAT CONTROLS UP/DOWN MOTION OF THE WRIST. NO FRAGMENTS FELL INSIDE OF THE PATIENT¿S ANATOMY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363269 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230803 0234 00886874119815

    Patients

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