BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST;DAVINCI SI

    MDR report key: 17045870 · Received June 2, 2023

    Report

    Report Number
    2955842-2023-15490
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    July 28, 2020
    Report Date
    July 29, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874111505
    PMA / PMN Number
    K180033
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE MCS INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE PROXIMAL CLEVIS. THE INSTRUMENT WAS RETURNED WITH A TIP COVER ACCESSORY WHICH THE THERMAL DAMAGE ALIGNS WITH THE THERMAL DAMAGE FOUND ON THE INSTRUMENT. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND NO ARCING WAS OBSERVED WHEN THE ENERGY DELIVERY TEST WAS PERFORMED. ELECTRICAL CONTINUITY WAS PERFORMED AND PASSED. THE INSTRUMENT TUBE EXTENSION EXHIBITS SIGNS OF SCRATCH MARKS/ABRASION. TUBE EXTENSION SCRATCH MARKS MEASURED ROUGHLY 0.048" X 0.157". THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS EXCESSIVE CONTACT WITH ABRASIVE OR HARD SURFACES DURING TRANSPORT OR REPROCESSING OR DURING TIP COVER INSTALLATION/REMOVAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON OBSERVED ARCING AND A THERMAL BURN TO THE PATIENTS BOWEL WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. IT IS REPORTED THAT THERE WAS MEDICAL INTERVENTION TO ADDRESS THE BOWEL INJURY; HOWEVER, AT THIS TIME IT IS UNKNOWN AS TO WHAT MEDICAL INTERVENTION WAS RENDERED TO THE PATIENT. IT WAS ALSO CONFIRMED THAT THE SURGEON FURTHER NOTICED THAT THE MCS TIP COVER ACCESSORY HAD A HOLE. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293207 ENDOWRIST;DAVINCI SI MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 420179-22 N11190327 233 00886874111505

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES