BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14941745 · Received July 7, 2022

    Report

    Report Number
    2955842-2022-12815
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    April 25, 2022
    Report Date
    June 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION REVEALED THE INSTRUMENT WAS PLACED AND DRIVEN ON A TEST SYSTEM AND WAS FOUND TO HAVE 1 LIFE REMAINING ALSO VERIFIED BY LOG FILES. THERE WAS NO PROBLEM DETECTED. ADDITIONAL FINDING REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE PROXIMAL END. THE CONDUCTOR WIRE WAS BROKEN AT THE WATERFALL PULLEY. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST THE ROOT CAUSE OF BROKEN CONDUCTOR WIRE IS TYPICALLY ATTRIBUTED TO MANUFACTURING. A REVIEW OF THE INSTRUMENT LOG FOR THE MCS INSTRUMENT (PN# 470179-19 LOT# K14210830-0018) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 ON SYSTEM SK4357 FOR APPROXIMATELY 1 HOUR 37 MINUTES. THE ALLEGED EVENT OCCURRED ON THE 9TH USE OF THE INSTRUMENT WITH 1 LIFE REMAINING. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT HAD CONDUCTOR WIRE DAMAGE. THE DAMAGED/BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD 1 LIFE BUT WHEN SEATED ON THE ARM IT SHOWED THE INSTRUMENT WAS EXPIRED. THE INSTRUMENT WAS WORKING AT THE BEGINNING OF THE PROCEDURE BUT THE SURGEON COULD NOT APPLY ENERGY MID PROCEDURE. INTEROPERATION CLEANING, CHANGING THE CORD, AND ADJUSTING THE ENERGY LEVEL UP TO 6 DIDN'T WORK. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE FOLLOW UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967532 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K14210830 0018 00886874112298

    Patients

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