BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11074716 · Received December 28, 2020

    Report

    Report Number
    2955842-2020-11402
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    September 15, 2020
    Report Date
    December 3, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE PROXIMAL END IN THE MAIN TUBE. THIS FAILURE MODE IS ATTRIBUTED TO AN ISSUE DURING MANUFACTURING. FURTHER INSPECTION OF THE INSTRUMENT WAS PERFORMED AND DAMAGE ON THE CONDUCTOR WIRE INSULATION AT THE PROXIMAL END WAS FOUND. THE INSTRUMENT WAS SUBJECTED TO ELECTRICAL CONTINUITY AND FAILED THE TEST. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO PROCEDURE VIDEO OR IMAGE WAS SUBMITTED TO ISI FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOT# N11190409 / SEQUENCE 0100 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE OF (B)(6) 2020 ON SYSTEM (B)(4).THE ALLEGED EVENT OCCURRED ON THE 9TH USE OF THE INSTRUMENT. THE INSTRUMENT HAD 1 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENTS ARE MULTIPLE-USE ELECTROSURGICAL ENDOSCOPIC INSTRUMENTS WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM AND AN EXTERNAL ELECTROSURGICAL UNIT (ESU). THE INSTRUMENT IS DESIGNED TO PROVIDE ENERGY FROM THE DESIGNATED LOCATION ON THE INSTRUMENT (THE TIP) TO THE PLANNED ANATOMICAL LOCATION WHEN USED AS INTENDED. THE ENERGY IS ACTIVATED BY PRESSING THE DESIGNATED PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THE INSTRUMENT & ACCESSORY USER MANUAL STATES: ¿ALWAYS HAVE A BACKUP INSTRUMENT OR ACCESSORY AVAILABLE TO COMPLETE THE SURGICAL PROCEDURE IN CASE OF INSTRUMENT FAILURE.¿ IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS UNABLE TO ACTIVATE ENERGY. NO SYSTEM ERROR WAS DISPLAYED DURING THE ISSUE. THE USER CONTINUED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. THE COMPLAINT ALLEGES THAT THERE IS NO ENERGY DELIVERED, THUS, THERE WAS NO RISK OF AN ADVERSE EVENT RELATED TO AN UNINTENDED ENERGY DISCHARGE TO THE PATIENT. THERE IS NO EVIDENCE THAT THE ISI DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT THE ISI DEVICE MALFUNCTIONED IN A WAY THAT COULD CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE FAILURE ANALYSIS IDENTIFIED THAT THE CONDUCTOR WIRE WAS BROKEN/DAMAGED AT THE MAIN TUBE/ROLL GEAR JUNCTION AT THE PROXIMAL END. WHILE THERE WAS NO HARM OR INJURY TO PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. DEVICE EXPIRATION DATE WAS LEFT BLANK AS THIS INSTRUMENT HAS 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THE INSTRUMENT HAS 1 REMAINING USABLE LIFE, THEREFORE, HAD NOT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS UNABLE TO ACTIVATE ENERGY. NO SYSTEM ERROR WAS DISPLAYED DURING THE ISSUE. THE USER CONTINUED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE TO THE INSTRUMENT WAS NOTED DURING INSPECTION. NO UNINTENDED ENERGY DISCHARGE OR ARCING WAS OBSERVED DURING THE PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2020 ON SYSTEM (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539878 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N11190409 0100 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1