BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18166579 · Received November 18, 2023

    Report

    Report Number
    2955842-2023-20458
    Event Type
    Malfunction
    Date Received
    November 18, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 31, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE SCRATCHED YAW PULLEY. THE PART IS CHIPPED AND THE EDGE IS SHARP. DURING VISUAL INSPECTION, THE EDGE SIDE OF THE YAW PULLEY HAS SEVERAL SCRATCHES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT, HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    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 CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS HAD A PART OF THE PLASTIC CHIPPED OFF AND THE EDGE BECAME SHARP. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880597 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10230629 0243 00886874119808

    Patients

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