BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST SP

    MDR report key: 20591966 · Received November 1, 2024

    Report

    Report Number
    2955842-2024-21174
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    October 4, 2024
    Report Date
    October 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114322
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT YET BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. A BROKEN PIECE, MEASURING APPROXIMATELY 3.82MM X 9.24MM, WAS NOT RETURNED WITH THE INSTRUMENT. DUE TO THE BROKEN MOLDED INSULATOR, A DETACHED FRAGMENT WAS OBSERVED THAT WAS NOT RETURNED WITH THE INSTRUMENT. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED GRIP TIP. THE DISLODGED GRIP TIP, MEASURING APPROXIMATELY 13.04MM X 4.23MM, WAS RETURNED WITH THE INSTRUMENT. THIS FAILURE IS LIKELY CAUSED BY THE BROKEN MOLDED INSULATOR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE DISTAL END. THE BREAK ON THE CONDUCTOR WIRE WAS LOCATED AT THE MOLDED INSULATOR. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST, CONFIRMING A COMPLETE BREAK IN THE WIRE. NO THERMAL DAMAGE WAS FOUND ON THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PART OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS BROKEN OFF DURING THE OPERATION (15 LIVES LEFT ON THE INSTRUMENT). THE CUSTOMER WAS ABLE TO RECOVER THE PIECE, AND IT WAS NOT LEFT IN THE PATIENT. THIS WILL ALSO BE SENT WITH THE RETURN. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THIS INCIDENT OCCURRED DURING A RALP. THE CUSTOMER COULD NOT EXACTLY SAY WHERE THEY WERE IN THE PROCEDURE. DURING THE PROCEDURE, THEY SUDDENLY SAW AN IRON WIRE COMING OUT OF THE INSTRUMENT AND THEN NOTICED THAT A PIECE WAS MISSING. THE CUSTOMER REMOVED THE INSTRUMENT AND WAS ABLE TO IMMEDIATELY FIND THE BROKEN PIECE IN THE ABDOMEN. AFTER A CHECK, IT WAS DETERMINED THAT IT WAS PROBABLY ONLY 1 PIECE SINCE IT FIT TOGETHER. AFTER THAT, THE CUSTOMER TOOK A NEW INSTRUMENT TO CONTINUE THE PROCEDURE. IN THE STAFF¿S OPINION, THERE HAS BEEN NO RESISTANCE OR ANYTHING WHILE USING THE INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166582 ENDOWRIST SP MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430010-62 U10240404 0011 00886874114322

    Patients

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