BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14254856 · Received April 29, 2022

    Report

    Report Number
    2955842-2022-11344
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 30, 2022
    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 Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS ON MULTIPLE ATTEMPTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS RETESTED AND PASSED ALL TESTING ON BOTH ATTEMPTS. THE HOUSING WAS REMOVED FOR INSPECTION AND THERE WAS NO DAMAGE FOUND ON THE INSTRUMENT IDENTIFICATION BOARD. THE INSTRUMENT WAS FULLY FUNCTIONAL. THE LOGS WERE UNAVAILABLE AT THIS TIME. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A LIFE INDICATOR WITH A FAILURE TO ROTATE. THE HOUSING WAS REMOVED AND FOUND THE LIFE INDICATOR DID NOT ROTATE WHEN THE INSTRUMENT EXPIRED. THE INSTRUMENT LOGS WERE UNAVAILABLE AT THIS TIME. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND SHOWED THE INSTRUMENT HAD 0 USE REMAINING. THE ROOT CAUSE IS NOT ESTABLISHED. UPON VISUAL INSPECTION, THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY AT THE DISTAL END. BOTH SIDES OF THE BIPOLAR YAW PULLEY EXHIBITED LOCALIZED MELTING. NO CONDUCTOR WIRE INSULATION DAMAGE WAS OBSERVED ON THE INSTRUMENT. THE ELECTRICAL CONTINUITY TEST WAS PERFORMED AND PASSED. THE ROOT CAUSE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THE SYSTEM WAS NOT CONNECTED TO ON SITE, AND THE INSTRUMENT WAS NOT REGISTERED ON THE SYSTEM. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED AT THIS TIME. REVIEW OF THE IMAGES REVEALED NO OBVIOUS DAMAGE ON FENESTRATED BIPOLAR FORCEPS INSTRUMENT. BASED ON THE ADDITIONAL INFORMATION OBTAINED FROM FAILURE ANALYSIS INVESTIGATION, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE BIPOLAR YAW PULLEY AT THE DISTAL END. BOTH SIDES OF THE BIPOLAR YAW PULLEY EXHIBITED LOCALIZED MELTING. NO CONDUCTOR WIRE INSULATION DAMAGE WAS OBSERVED. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE THERMAL DAMAGE TO OCCUR. 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. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. PMA/510(K) NUMBER AND ADVERSE EVENT ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START (POST-ANESTHESIA AND AFTER PORT PLACEMENT) OF A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT BEING RECOGNIZED AFTER INSTALLATION AND SHOWING A YELLOW INDICATOR. THE CUSTOMER RESEATED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND COMPLETED THE PROCEDURE WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE ISSUE WAS DISCOVERED AFTER THE CUSTOMER INSERTED THE INSTRUMENT. NO ARCING OR INSTRUMENT COLLISION WERE OBSERVED DURING THE SURGICAL PROCEDURE. A VIDEO RECORDING OF THE PROCEDURE IS NOT AVAILABLE, BUT IMAGES OF THE INSTRUMENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437176 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N11210503 0038 00886874112359

    Patients

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