BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1133567 · Received August 22, 2008

    Report

    Report Number
    2955842-2008-01236
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF THE INSTRUMENT IS RETURNED FOR EVALUATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, AT THE START OF THE DISSECTION, THE PERMANENT CAUTERY HOOK INSTRUMENT BEGAN TO ARC FROM THE NECK OF THE INSTRUMENT. THE SURGEON IMMEDIATELY REMOVED THE PERMANENT CAUTERY HOOK INSTRUMENT AND REPLACED IT WITH ANOTHER INSTRUMENT OF THE SAME TYPE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH REPLACEMENT INSTRUMENT. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420183

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR ACCESSORIES| DA VINCI S SURGICAL SYSTEM| ELECTROSURGICAL UNIT