BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10281319 · Received July 16, 2020

    Report

    Report Number
    2955842-2020-10648
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    May 22, 2020
    Report Date
    June 19, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G4, G7 AND H2. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: G6 - 510K NUMBER K131861 WAS ADDED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE PROXIMAL END IN THE WATERFALL PULLEYS. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THE BROKEN CONDUCTOR WIRE IS DUE TO A MANUFACTURING RELATED ISSUE. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS (PART # 470205-17/ LOT # N10190106-0118) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2020 ON SYSTEM SK2751. THE ALLEGED EVENT OCCURRED ON THE 6TH USE OF THE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED BECAUSE THE BIPOLAR INSTRUMENT HAD CONDUCTOR WIRE DAMAGE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, OR NOT PROVIDED. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. THE INFORMATION FOR FIELDS IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS (FBF) HAD NO ENERGY ACTIVATED. THERE WAS NO IMPROVEMENT AFTER REPLACING THE BIPOLAR CABLE. A BACKUP FBF INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE OPERATING ROOM (OR) NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ARCING OR SMOKING EVENT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748023 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N10190106 0118 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR DA VINCI INSTRUMENTS AND ACCESSORIES