BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2882472 · Received December 20, 2012

    Report

    Report Number
    2955842-2012-01391
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 21, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH THE CERAMIC SLEEVE CRACKED AND BROKEN AT THE TIP, EXPOSING A PORTION OF THE SPATULA. ENGINEERING CONCLUDED THAT THE DAMAGE WAS LIKELY DUE EXCESS FORCE CONTACT AT THE CERAMIC SLEEVE SURFACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE SURGEON NOTED THAT A SMALL PIECE OF PLASTIC ON THE TIP OF THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS MISSING. THERE WAS NO REPORT THAT THE BROKEN PIECE FELL INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND 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 M10120817 930

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SURG SYSTEM, ACCESSORIES AND ESU