BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 17066367 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-15651
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 9, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND PATIENT`S INJURY CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE MCS INSTRUMENT INVOLVED WITH THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE DEVICE LOGS FOR THE MONOPOLAR CURVED SCISSORS INSTRUMENT (PART#: 470179-19 / LOT#: K14220530-0082) ASSOCIATED WITH THIS EVENT WAS PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2023 VIA SYSTEM SK5557 FOR A UNILATERAL INGUINAL HERNIA PROCEDURE. THERE WERE 8 USES REMAINING AFTER THIS LAST USAGE. THERE IS NO INDICATION THAT THE INSTRUMENT WAS USED IN SUBSEQUENT PROCEDURES AFTER THE ALLEGED EVENT REPORTED IN THIS RECORD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, AN ARCING EVENT OCCURRED FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, POSSIBLY DUE TO CONTACT BETWEEN THE MCS AND THE CADIERE FORCEPS INSTRUMENTS. THE PATIENT EXPERIENCED BURNS ON THEIR ANTERIOR ABDOMINAL WALL, AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITHOUT OTHER ISSUES. DETAILS REGARDING THE ARCING EVENT, THE SCOPE AND SEVERITY OF THE BURNS, ANY MEDICAL OR SURGICAL INTERVENTIONS REQUIRED, AND THE PATIENT'S CURRENT STATUS ARE UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE FOR ADDITIONAL INFORMATION, HOWEVER, AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530483 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 N/A

    Patients

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