BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10287441 · Received July 17, 2020

    Report

    Report Number
    2955842-2020-10652
    Event Type
    Malfunction
    Date Received
    July 17, 2020
    Date of Event
    May 6, 2020
    Report Date
    June 22, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MBF INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION DID NOT REPLICATE NOR CONFIRM THE REPORTED ISSUE. THE MBF INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE MBF INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE MBF INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. ADDITIONAL FINDINGS NOT REPORTED BY SITE: THE MBF INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. AFTER OPENING THE HOUSING, A SEGMENT OF CONDUCTOR WIRE WAS FOUND TO BE BROKEN INSIDE OF THE MAIN TUBE OF THE PROXIMAL END OF THE INSTRUMENT. A REVIEW OF THE INSTRUMENT LOG FOR THE MBF INSTRUMENT (470172-16/N10191011 0127) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. THE MBF INSTRUMENT WAS LAST USED ON 5/6/2020 ON SYSTEM SL0237. THE ALLEGED EVENT OCCURRED ON THE 8TH USE. THERE WAS NO INDICATION THAT THE MBF INSTRUMENT WAS USED IN SUBSEQUENT PROCEDURES AFTER THE ALLEGED EVENT REPORTED ON THIS RECORD. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT HAD CONDUCTOR WIRE DAMAGE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. ALTHOUGH THERE WAS NO PATIENT HARM REPORTED, IF THE MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, OR NOT PROVIDED. THE EXPIRATION DATE IS NOT APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT HAD 2 LIVES LEFT BUT WAS NOT RECOGNIZED BY THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755718 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N10191011 0127 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1