BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18591517 · Received January 26, 2024

    Report

    Report Number
    2955842-2024-10723
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 13, 2023
    Report Date
    January 10, 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
    BE
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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 FAIL THE ELECTRICAL CONTINUITY TEST. THE CONDUCTOR WIRE WAS FOUND BROKEN AT THE CRIMP DURING VISUAL INSPECTION. ALSO, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE YAW PULLEY. THE CONDUCTOR WIRE WAS BROKEN AT THE GRIP-CRIMP LOCATION. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. NO SIGNS OF THERMAL DAMAGE WERE OBSERVED. THE INSTRUMENT'S GRIP-TIPS AND BIPOLAR YAW PULLEY WERE FOUND HEAVILY CONTAMINATED WITH DRY BIO/DEBRIS. NO THERMAL DAMAGE WAS OBSERVED. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS WERE 0.061¿ - 0.440" IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. 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 H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THERE WAS NO COAGULATION ON THE TIP OF THE MARYLAND BIPOLAR FORCEPS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROBLEM HERE WAS THAT THE COAGULATION STILL REACHED THE CLAMP, BUT NO LONGER COAGULATED ON THE LEGS THEMSELVES. THIS CAUSED CURRENT AND COAGULATION TO OCCUR IN THE WRONG PLACE, NAMELY THE HINGE. IN ADDITION, THERE WAS A FEW MINUTES DELAY IN GETTING A NEW INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533390 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-16 K10211213 0037 00886874119792

    Patients

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