BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2851888 · Received November 29, 2012

    Report

    Report Number
    2955842-2012-01127
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 18, 2012
    Report Date
    November 1, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF INSTRUMENT WITH BULGING CABLE WAS NOT CONFIRMED. INSTRUMENT WAS FOUND WITH CERAMIC SLEEVE BROKEN AT THE SPATULA BASE, EXPOSING THE SHAFT OF THE SPATULA. A PIECE APPROXIMATELY 0.16 X 0.06 BROKE OFF FROM THE CERAMIC SLEEVE. EVIDENCE NOT CONCLUSIVE, BUT DAMAGE LIKELY DUE TO EXCESS FORCE CONTACT ON THE SLEEVE. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT HAD A WIRE STICKING OUT AT THE DISTAL END. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10111130 594

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES