BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17015569 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14705
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    August 5, 2021
    Report Date
    August 24, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. NO FUNCTIONAL TESTING COULD BE PERFORMED ON AN IN-HOUSE SYSTEM DUE TO THE DAMAGED CONDITION OF THE INSTRUMENT. IT WAS UNABLE TO TEST, AND THE ISSUE COULD NOT BE REPRODUCED. OBSERVATION(S) NOT REPORTED BY SITE WAS THAT THE INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE BROKEN. A PIECE MEASURING APPROXIMATELY 0.273 X 0.558 WAS NOT RETURNED WITH THE INSTRUMENT. THE ENTIRE DISTAL TIP IS SEPARATED WHERE IT INSTALLS ONTO THE MAIN TUBE. ALL THE CABLES ARE BROKEN. THE BROKEN DISTAL TIP WAS RETURNED WITH THE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP CABLE AT THE PROXIMAL CLEVIS CABLE HOLE. THE IDLER PULLEYS AT THE PROXIMAL CLEVIS SPUN FREELY AND DID NOT EXHIBIT ANY DAMAGE. THE HOUSING WAS REMOVED FROM THE BACK END, NO ADDITIONAL DAMAGE WAS FOUND. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE ROOT CAUSE FOR THE BROKEN PITCH CABLES IS COMMONLY ATTRIBUTED TO MISHANDLING/MISUSE. THE ROOT CAUSES FOR EACH INDIVIDUAL CODE ARE ALL IN RELATION AND ATTRIBUTED TO MISHANDLING/MISUSE DUE TO THE USER BREAKING THE INSTRUMENT IN ORDER TO REMOVE IT FROM THE CANNULA BASED ON REVIEW OF THE COMPLAINT SUMMARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UTERINE MYOMECTOMY SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT DID NOT MOVE. UPON INSPECTION OF THE ARM, THE WRIST WAS FOUND TO BE FALLEN OUT AND BENT. WHILE ATTEMPTING TO PULL IT OUT FROM TROCAR, THE WRIST BROKEN CAUSING CABLE BREAKAGE. BACKUP INSTRUMENT OF SAME KIND WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO FRAGMENT FELL INSIDE OF THE PATIENT'S ANATOMY. THE WIRE WAS BROKEN BECAUSE THE CUSTOMER BROKE AXIS OF THE WRIST. THE WRIST BREAKAGE CAUSED THE WIRES TO BREAK. INFORMATION REGARDING RELEVANT TESTING AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609291 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-05 N10210301 0279 00886874112342

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES