BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19534988 · Received June 14, 2024

    Report

    Report Number
    2955842-2024-15835
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 3, 2024
    Report Date
    May 21, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE FOLLOWING THE DEVICE TECHNOLOGIES PRODUCT COMPLAINTS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION: THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS OBSERVED. THE ISSUE OCCURRED WHILE SUTURING AND 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 OR LEFT/RIGHT (YAW) MOTION OF THE GRIPS OR UP/DOWN (PITCH) MOTION OF THE WRIST. THERE WERE NOT ANY CABLES VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT. NO PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE AVAILABLE FOR ISI REVIEW.

    Additional Manufacturer Narrative · 0

    THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE GRIP HUB. 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 COULD HAVE CONTRIBUTED TO THE CABLE BREAKING.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 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.

    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 SACROCOLPOPEXY SURGICAL PROCEDURE, THE MEGA SUTURECUT NEEDLE DRIVER HAD A SNAPPED WIRE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY USING A BACKUP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153483 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-15 K10230824 0331 00886874119815

    Patients

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