BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20617661 · Received November 6, 2024

    Report

    Report Number
    2955842-2024-21614
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    July 23, 2024
    Report Date
    October 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND THE PRIMARY FAILURE OF COULD NOT REPRODUCE TO BE RELATED TO THE CUSTOMER 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. THERE WERE NO ISSUES WITH CLOSING DURING INSPECTION. NO GRIP MISALIGNMENT. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES. ADDITIONAL FINDINGS NOT RELATED TO CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE LOCALIZED MELTING NEAR THE GRIP BASE. THIS FAILURE IS MOST COMMONLY CAUSED BY INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATH. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TESTS. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, MARYLAND BIPOLAR FORCEPS WAS DIFFICULT TO CLOSE DURING USE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FOLLOW-UP INFORMATION WAS GATHERED FROM TSUCHIDA/ MEDICAL ENGINEER. IT IS UNKNOWN IF THERMAL DAMAGE WAS OBSERVED. IT IS UNKNOWN IF ARCING WAS OBSERVED DURING THE PROCEDURE. PATIENT DEMOGRAPHIC WAS NOT PROVIDED. NO, PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW. THE PATIENT INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461983 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11231109 0066 00886874119792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES