BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 1923346 · Received December 13, 2010

    Report

    Report Number
    2955842-2010-00548
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 27, 2010
    Report Date
    November 17, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND THE CERAMIC SLEEVE TO BE CHIPPED AD THE BASE OF THE SPATULA. NO ADDITIONAL CRACKS WERE FOUND ON THE SLEEVE AND NO ARC TRAC WAS EVIDENT ON THE SLEEVE OR CLEVIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    ON (B)(6), 2010 , MEDWATCH UF/IMPORTER REPORT (B)(4) WAS RECEIVED: EVENT DESC: SURGEON NOTICED A PIECE OF METAL INSIDE THE PATIENT'S ABDOMEN. FURTHER INVESTIGATION NOTED THAT PART OF THE ROBOTIC PERMANENT CAUTERY SPATULA INSTRUMENT WAS CRACKED AND MISSING A PIECE. THE PIECE WAS REMOVED FROM THE ABDOMEN AND TAKEN ODD THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-04 S10090424 056

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES