BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 17015641 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14768
    Event Type
    Injury
    Date Received
    May 27, 2023
    Date of Event
    November 9, 2021
    Report Date
    November 9, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121504
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE LARGE SUTURE CUT NEEDLE DRIVER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE GRIP BASE. A PIECE APPROXIMATELY 0.084" X 0.30" WAS FOUND TO BE BROKEN OFF THE YAW PULLEY. THE BROKEN PIECE WAS RETURNED. THE CAUSE OF BROKEN GRIP TIPS IS TYPICALLY ATTRIBUTED TO EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, A LARGE SUTURE CUT NEEDLE DRIVER TIP BROKE OFF IN THE PATIENT. THE CLINICAL SALES REPRESENTATIVE (CSR) CALLED TECH SUPPORT BUT WAS NOT ON SITE. THE CUSTOMER HAD CALLED HIM AND SENT IMAGES. THE TSE ASKED IF ALL PARTS OF THE INSTRUMENT HAD BEEN CLEARED OF THE PATIENT AND THE CALLER INDICATED THAT THE OR STAFF WAS RETRIEVING PART(S) AT THE TIME OF THE CALL. THE CALLER TO CALL BACK AND CONFIRM WHEN ALL ACCOUNTED FOR. THE CSR CALLED BACK AND CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THE SITE WAS COMPLETING THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT WAS RETRIEVED LAPAROSCOPICALLY. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THE CUSTOMER PERFORMED ADDITIONAL 2-HOUR LAPAROSCOPY AND NEEDED AN X-RAY INTRA-OPERATIVELY. THE SURGEON BELIEVED THAT THE CAUSE OF THE FRAGMENT WAS ATTRIBUTED TO THE INSTRUMENT BREAKAGE WHILE PICKING UP AN ANVIL TO PUT INSIDE THE COLON CONDUIT. THE INSTRUMENT WAS IN USE FOR ABOUT 5 MINUTES WHEN THE ISSUE OCCURRED. THE INSTRUMENT WAS INSPECTED BEFORE USE BY A SCRUB TECH. NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS NOTED. THERE WERE NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT NOTED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER HARD A MATERIAL OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE CASE PRIOR TO THE BREAKAGE. THE SURGEON DID NOT FEEL ANY RESISTANCE UPON THE INSTRUMENT REMOVAL. IT WAS REMOVED WITH A STRAIGHTENED WRIST. NO OTHER DAMAGE WAS SEEN REMOVAL. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH POST-OP COMPLICATIONS RELATED TO THE FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849824 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-07 N10210316 0017 00886874121504

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES