BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI

    MDR report key: 20625547 · Received November 6, 2024

    Report

    Report Number
    2955842-2024-21622
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 14, 2024
    Report Date
    October 14, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    04250480109038
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND WAS FOUND WITH A MELTED FIBER CONNECTOR. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE HANDHELD CAMERA LIGHT GUIDE FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE SURGICAL STAFF DISCONNECTED THE HANDHELD CAMERA LIGHT GUIDE BUT DID NOT TURN THE LIGHT SOURCE OFF AND SET IT DOWN ON THE BED. THE CALLER REPORTED THAT THE SURGICAL STAFF FOUND THE HANDHELD CAMERA LIGHT GUIDE HAD BURNED THROUGH THE DRAPE AND BED PADDING, AND IT HIT THE STRAP NEAR THE PATIENT. THE CALLER STATED THAT THERE WAS NO PATIENT INJURY, BUT THE HANDHELD CAMERA LIGHT GUIDE WAS DAMAGED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED BEST PRACTICES FOR THE HANDHELD CAMERA LIGHT GUIDE TO NOT LEAVE THE LIGHT SOURCE ON WHEN NOT IN USE AND NOT TO LEAVE THE LIGHT SOURCE UNATTENDED. IT WAS NOTED THAT THE HANDHELD CAMERA LIGHT GUIDE REMAINED HOT AFTER USE AND HAD BURNED THROUGH LAYERS OF THE DRAPE BLANKET AND A PORTION OF THE BELT PAD. IT APPEARED BLACKENED AND CHARRED ON BOTH METAL TIPS/ENDS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416790 DA VINCI N/A NAY INTUITIVE SURGICAL, INC 470656-01 N/A 04250480109038

    Patients

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