BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19834793 · Received July 26, 2024

    Report

    Report Number
    2955842-2024-17448
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 4, 2024
    Report Date
    July 5, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED THAT THE MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENT BE RETURNED FOR FAILURE ANALYSIS (FA) TESTING. THE PRODUCT HAS BEEN RECEIVED AND THE FA IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    THE MEGA SUTURECUT NEEDLE DRIVER (MSND) INSTRUMENT HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO REPLICATE AND CONFIRMED THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE PROXIMAL CLEVIS HOLE. THE CABLE WAS FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID NOT EXHIBIT ABNORMAL SHARP EDGES OR DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE MEDICAL ENGINEER: THE ISSUE WAS NOT RELATED TO OPENING/CLOSING OF THE GRIPS, LEFT/RIGHT (YAW) MOTION OF THE GRIPS, OR UP/DOWN (PITCH) MOTION OF THE WRIST. NO CABLE WAS VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MEGA SUTURE CUT NEEDLE DRIVER (MSND) INSTRUMENT HAD A BROKEN OR LOOSE CABLE. THE CUSTOMER USED A BACKUP MSND INSTRUMENT TO CONTINUE WITH THE PROCEDURE. NO FRAGMENT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    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
    459282 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 K10230914 0023 00886874119815

    Patients

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