BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 16925250 · Received May 13, 2023

    Report

    Report Number
    2955842-2023-13168
    Event Type
    Injury
    Date Received
    May 13, 2023
    Date of Event
    May 12, 2021
    Report Date
    May 12, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112496
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS FOUND TO HAVE THE MAIN TUBE BROKEN. A PIECE MEASURING APPROXIMATELY 0.134 X 0.239 WAS NOT RETURNED WITH THE INSTRUMENT. THIS FAILURE IS TYPICALLY ASSOCIATED WITH MISHANDLING/MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS INSERTED WITH NO DIFFICULTY. AFTER A COLLISION WITH THE CAMERA, THE INSTRUMENT WOULD NOT RESPOND APPROPRIATELY. AN ATTEMPT TO REMOVE THE INSTRUMENT WAS MADE, THE INSTRUMENT WAS THEN NOTICED TO BE OFF AND SPLINTERED AT THE METAL TO PLASTIC SHAFT JUNCTION, MAKING THE INSTRUMENT TOO LARGE TO PULL THROUGH THE TROCAR. PIECES OF THE SPLINTERED SHAFT WERE RECOVERED BY THE SURGEON. THE INSTRUMENT AND THE TROCAR WERE REMOVED TOGETHER AND WILL BE SENT BACK TO INTUITIVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SITE ROBOTICS COORDINATOR AND ADDITIONAL INFORMATION WAS OBTAINED: THE FRAGMENTS WERE RETRIEVED AND DISCARDED. NO POST-OPERATIVE TESTS WERE PERFORMED BECAUSE THEY WOULD NOT HAVE BEEN VISIBLE UNDER X-RAY. SHE STATED THE INSTRUMENT BROKE NEAR THE END OF THE CASE. SHE HAS NOT HEARD OF ANY COMPLICATIONS TO THE PATIENT POST-PROCEDURE. SHE DID NOT WANT TO PROVIDE ANY PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043938 ENDOWRIST TIP-UP FENESTRATED GRASPER NAY INTUITIVE SURGICAL, INC 470347-11 N11191119 0032 00886874112496

    Patients

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