BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 1232775 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01386
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CADIERE FORCEPS INSTRUMENT WAS NOT RETURNED FOR EVAL. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S MYOMECTOMY PROCEDURE, WHILE REPAIR OF THE UTERUS AFTER FIBROID DISSECTION, THE CADIERE FORCEPS INSTRUMENT RUBBED AGAINST ANOTHER CADIERE FORCEPS INSTRUMENT CAUSING FRAGMENTS FROM THE INSTRUMENT SHAFT TO FALL INTO THE SURGICAL SITE. FRAGMENTS WHERE REMOVED AND THE DAMAGED INSTRUMENT WAS TAKEN OUT OF SERVICE. THE INSTRUMENT WAS IN USE APPROX 20 MINUTES WHEN THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT INSTRUMENT OF THE SAME TYPE. THE INCIDENT LENGTHENED THE PROCEDURE AN UNDETERMINED AMOUNT OF TIME. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC ACCESSORY GCJ INTUITIVE SURGICAL, INC. 420049-05 0712101 450

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other ACCESSORIES| DA VINCI SURGICAL SYSTEM INSTRUMENT