BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1903894 · Received November 20, 2010

    Report

    Report Number
    2955842-2010-00504
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE CONDUCTOR CAP IS MISSING FROM THE DISTAL END; HOWEVER, THE CAP WAS NOT RETURNED WITH INSTRUMENT. THE CONDUCTOR WIRE IS EXPOSED BETWEEN THE DISTAL CLEVIS AND YAW PULLEY AS A RESULT OF THE DAMAGE. THE YAW PULLEY EXTRUDED BOSS FEATURE THAT MATES WITH THE CAP IS BROKEN OFF, WHICH ALLOWED THE CAP TO SLIP OUT. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI THYMECTOMY PROCEDURE, A PIECE OF THE PLASTIC WHEEL ON THE PERMANENT CAUTERY SPATULA INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH AN INSTRUMENT OF THE SAME TYPE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-05 M10100329 270

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR DA VINCI SI SURG SYS, INSTRMNTS, ACCESSORIES, ESU