BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18560186 · Received January 22, 2024

    Report

    Report Number
    2955842-2024-10515
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS MEASURES APPROXIMATELY 0.045¿ TO 0.207¿ IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. ONE OF THE BLADE EDGES WAS INDENTED, WHICH PREVENTED THE BLADES FROM CLOSING. THE INSTRUMENT WAS FOUND TO HAVE DRIED RESIDUE AROUND THE CLAMPING PULLEY CABLE GROOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD A CRACKED INSULATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532864 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K11220110 0034 00886874112298

    Patients

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