BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20660863 · Received November 12, 2024

    Report

    Report Number
    2955842-2024-21839
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 16, 2024
    Report Date
    October 20, 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
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE DAMAGED CONDUCTOR WIRE INSULATION, AND THE INTERNAL CONDUCTOR WIRES WERE EXPOSED. ALTHOUGH THE CONDUCTOR WIRE INSULATION WAS DAMAGED, THE INTERNAL WIRE WAS NOT FRAYED OR FULLY BROKEN. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. IMAGE REVIEW: A REVIEW OF THE PROVIDED IMAGES WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE GRIP CABLE MIGHT BE FRAYED OR BROKEN IN AREAS HIGHLIGHTED BY RED ARROWS. THE CONDUCTOR WIRE INSULATION APPEARS TO BE DAMAGED AND BARE METAL WIRE EXPOSED IN A SMALL AREA THAT THE YELLOW ARROW WAS POINTING TO. 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

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE 8MM MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE THE WIRE PEELED OFF. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT PRIOR TO PORT PLACEMENT, THE CONDUCTOR WIRE WAS FOUND EXPOSED DUE TO DAMAGED INSULATION. THERE WAS NO LOSS OF CAUTERY ASSOCIATED WITH DAMAGED CABLE. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. ALSO, NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977179 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K11240104 0052 00886874119792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES