BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19283559 · Received May 10, 2024

    Report

    Report Number
    2955842-2024-14479
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    January 24, 2024
    Report Date
    April 16, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER DID NOT CALL-IN CUSTOMER SERVICE TO CREATE RMA FOR THE REPORTED INSTRUMENT. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE..

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CABLE AT THE TIP OF MEGA SUTURECUT NEEDLE DRIVER CAME OUT AND WERE VISIBLE. THERE WAS NO REPORTED INJURY. ON 04/16/2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT (B)(4) STATING: THE WIRES AT THE TIP OF THE MEGA SUTURECUT NEEDLE DRIVER CAME OUT AND WERE VISIBLE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS UNKNOWN IF INSTRUMENT WAS INSPECTED PRIOR TO USE. NURSE WAS UNSURE WHAT SURGICAL TASK WAS BEING PERFORMED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. MULTIPLE CABLES WERE VISIBLY PROTRUDING FROM THE DISTAL END OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840173 ENDOWRIST MEGA SUTURECUT ND NAY INTUITIVE SURGICAL, INC 471309-16 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES.