BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 13501859 · Received February 9, 2022

    Report

    Report Number
    2955842-2022-10211
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    December 28, 2021
    Report Date
    January 18, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) WAS NOT ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. UPON VISUAL INSPECTION, THE JAW CERAMIC DOTS WERE PRESENT. ENERGY WAS DELIVERED WITHOUT ANY ISSUES AND THE ELECTRIC CONTINUITY TEST PASSED. A REVIEW OF LOGS SHOWED NO FAILURES. THE KNIFE SLOT TEST PASSED WITH THE 0.027" PIN AND THE GAP TEST PASSED WITH THE 0.004" GAGE. ROOT CAUSE CANNOT BE TRACED DEVICE. A REVIEW OF THE INSTRUMENT LOG OF THE VESSEL SEALER EXTEND (PART # 480422-01/ LOT # M90211006-0159 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS LAST USED ON 28-DEC-2021 ON SYSTEM SK2418. THIS IS A SINGLE USE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THE VESSEL SEALER EXTEND INSTRUMENT DID NOT CAUTERIZE. IT IS UNKNOWN IF THERE WERE AUDIBLE BEEPS FROM THE GENERATOR, INDICATING THAT THE SEAL WAS COMPLETE. THE GENERATOR USED WITH THE VESSEL SEALER EXTEND INSTRUMENT AND DA VINCI SYSTEM IS DESIGNED TO PROVIDE A SUCCESSFUL CONFIRMATION SIGNAL TO INDICATE SEAL COMPLETION. HOWEVER, IT IS UNKNOWN IF THERE WAS A SUCCESSFUL CONFIRMATION SIGNAL FOLLOWING THE REPORTED SEALING CYCLE ATTEMPT. PER THE DESCRIPTION OF THE COMPLAINT, THE VESSEL SEALER EXTEND MAY HAVE INCURRED A FAILURE MODE THAT IS KNOWN TO IMPACT SEALING EFFECTIVENESS. DEFICIENCIES IN SEALING MAY LEAD TO INADEQUATE HEMOSTASIS. 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 GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, A VESSEL SEALER EXTEND INSTRUMENT WOULD NOT CAUTERIZE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (IS) MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258824 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 M90211006 0159 10886874115661

    Patients

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