BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14191129 · Received April 24, 2022

    Report

    Report Number
    2955842-2022-11229
    Event Type
    Malfunction
    Date Received
    April 24, 2022
    Date of Event
    December 14, 2021
    Report Date
    March 24, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED THE DEVICE INVESTIGATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THERE WAS NO OBVIOUS DAMAGE TO THE CONDUCTOR WIRES. THE ROOT CAUSE IS NOT DETERMINABLE/APPLICABLE. THE INSTRUMENT WAS TRANSFERRED TO INTUITIVE SURGICAL, INC. (ISI) ADVANCE FAILURE ANALYSIS (AFA) FOR FURTHER INVESTIGATION. ISI ADVANCE FAILURE ANALYSIS (AFA) CONFIRMED THE INITIAL FA FINDINGS. WHEN THE REAR HOUSING OF THE FENESTRATED BIPOLAR FORCEPS WAS REMOVED, AFTER THE GRIP TABLES CABLES WERE CUT, ONE OF THE CONDUCTOR WIRES WAS FOUND TO BE BROKEN AT THE PROXIMAL END OF THE TUBE JUST ENTERING THE PEEK TUBE. THE ROOT CAUSE APPEARED TO BE COMPONENT FAILURE. A REVIEW OF THE INSTRUMENT LOG FOR THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT (471205-17/ K14210913 0223) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS LAST USED IN A PROCEDURE ON 14-DEC-2021 VIA SYSTEM SK3393. THE ALLEGED INSTRUMENT HAD 10 USES REMAINING AFTER THE LAST PROCEDURAL USE. AN EVENT VERIFICATION CONFIRMED THE PROCEDURE WAS PERFORMED ON THE REPORTED EVENT DATE. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND THAT THERE WERE NO OTHER COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR VIDEO OF THE PROCEDURE WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED AS A REPORTABLE MALFUNCTION EVENT BASED ON THE FAILURE ANALYSIS FINDINGS: THE INSTRUMENT HAD CONDUCTOR WIRE DAMAGE WITH NO EVIDENCE OF USER MISHANDLING OR MISUSE. THE 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 NEPHRECTOMY SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT STOPPED WORKING. THE CUSTOMER CHANGED THE PORTS AND CORDS BUT THE INSTRUMENT STILL DID NOT WORK. THE CUSTOMER REPLACED THE INSTRUMENT WITH THE SAME CORD AND IT WORKED FINE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. THE FENESTRATED BIPOLAR FORCEPS IS A MULTIPLE-USE ELECTROSURGICAL ENDOSCOPIC INSTRUMENT 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). INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2022: THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953524 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K14210913 0223 00886874119808

    Patients

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