BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2193050 · Received August 5, 2011

    Report

    Report Number
    2955842-2011-00256
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K002489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND THE INSTRUMENT TO BE RETURNED WITH A DARK RED AND BROWN OBJECT APPROXIMATELY .095 INCHES BY .095 INCHES IN SIZE AND SEPARATED FROM THE INSTRUMENT. VISUAL INSPECTION OF THE OBJECT UNDER MAGNIFICATION CONCLUDED THAT THE OBJECT IS NOT PART OF THE INSTRUMENT, HOWEVER, IT IS A CHARRED PIECE OF BIO DEBRIS. ENGINEERING ALSO OBSERVED THE SPATULA EXHIBITS MELTING AND THERMAL DEFORMATION AT THE DISTAL END AND THE SURFACE HAS A DARK DISCOLORATION. THE CERAMIC SLEEVE WAS FOUND TO BE BROKEN AT THE DISTAL END, EXPOSING A SECTION OF THE SPATULA SHANK. BROKEN PIECES WERE NOT RETURNED WITH THE INSTRUMENT. THE PROXIMAL CLEVIS WAS FOUND TO BE CRACKED BETWEEN THE EARS, WITH THE CRACKING OBSERVED CONSISTENT WITH OVERLOADING AT THE TIP. ENGINEERING CONCLUDED THE DAMAGE FOUND WAS LIKELY DUE TO MISHANDLING AND OR MISUSE OF THE INSTRUMENT. PER THE CASE NOTES ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PULMONARY WEDGE RESECTION PROCEDURE, WHILE USING THE PERMANENT CAUTERY SPATULA INSTRUMENT, THE SITE NOTICED A SMALL BLACK OBJECT INSIDE THE PATIENT. THE SURGEON REMOVED THE OBJECT AND BELIEVED IT TO BE PART OF THE PERMANENT CAUTERY SPATULA INSTRUMENT. 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. 420184-04 S10091008 380

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM INSTRUMENTS, ACCESSORIES, & ESU