BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17028353 · Received May 30, 2023

    Report

    Report Number
    2955842-2023-15261
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    August 13, 2021
    Report Date
    August 17, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED/CONFIRMED THE REPORTED EVENT. BASED ON REVIEW OF THE LOGS FROM DSP AND REMOTEFE, THE INSTRUMENT WAS FOUND TO HAVE SEVERAL HOMING FAILURES WITH ERROR CODE 22026: "INF: VESSEL SEALER FAILED DURING HOMING ON PCTP, TOOL ID 5800887- RFID 168853671." THE FAILURE WAS REPLICATED DURING IN-HOUSE TESTING. THE INSTRUMENT FAILED THE SELF-TEST. THE ROOT CAUSE FOR THIS FAILURE IS RELATED TO THE BENT KNIFE CABLE. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE DISLODGED BLADE. VISUAL INSPECTION SHOWED THAT THE BLADE WAS EXPOSED OUTSIDE OF THE BLADE GARAGE 0.072". NO DAMAGE WAS FOUND ON THE BLADE OR BLADE EDGE. NO CONDUCTOR WIRE DAMAGE OR SNAKE WRIST DAMAGE WAS FOUND. THERE WAS NO BIO DEBRIS FOUND AT THE INSTRUMENT TIP. A REVIEW OF REMOTEFE LOG SHOWED NO BLADE EXPOSED FAILURES. THE ROOT CAUSE OF DISLODGED INSTRUMENT BLADES IS RELATED TO THE KNIFE CABLE BEING BENT. VISUAL INSPECTION OF THE INSTRUMENT FOUND THE KNIFE CABLE TO BE BENT. THE ROOT CAUSE FOR THIS FAILURE IS NOT DETERMINABLE. ADDITIONALLY, THE BLADE WAS RETRACTED BACK INTO THE KNIFE SLOT AND PLACED ON THE SYSTEM FOR A SECOND TIME AND THE INSTRUMENT CONTINUED TO FAIL THE IN INITIALIZATION TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NISSEN FUNDOPLICATION SURGICAL PROCEDURE, A VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS NOT RECOGNIZED BY THE SYSTEM. THE CUSTOMER OPENED A NEW VSE WHICH WAS RECOGNIZED SUCCESSFULLY AND CASE PROCEEDED. PER COMPLAINT DETAILS AND SUBSEQUENT FOLLOW-UP, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AS IT COULD NOT BE COMPLETED ROBOTICALLY. DETAILS REGARDING THE CONVERSION WERE NOT PROVIDED. THE OPEN PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837475 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.