BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19590565 · Received June 22, 2024

    Report

    Report Number
    2955842-2024-16144
    Event Type
    Malfunction
    Date Received
    June 22, 2024
    Date of Event
    May 30, 2024
    Report Date
    May 31, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE THE CERAMIC SLEEVE DISLODGED FROM ITS NORMAL POSITION ON THE YAW PULLEY. CERAMIC SLEEVE DOES NOT HAVE MISSING MATERIAL. THERE WAS MINIMAL SILICONE ADHESIVE ON THE YAW PULLEY AND INSIDE THE CERAMIC SLEEVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT HAD THE BLACK PLASTIC "CONE" DISTAL TO THE TIP BROKEN.

    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
    1068242 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 K13220307 0149 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES