BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2182455 · Received July 28, 2011

    Report

    Report Number
    2955842-2011-00243
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE TIP COVER TO HAVE VARIOUS MECHANICAL TEARS AND HOLES BURNED THROUGH THE SILICONE. THE SILICONE EXHIBITS LOCALIZED MELTING AROUND THE HOLES, INDICATIVE OF ARCING. THE HOLE SIZES ARE .015 INCHES AND .020 INCHES AND ARE LOCATED FROM .190 INCHES TO .295 INCHES ABOVE THE SILICONE TO SLEEVE INTERFACE. THE TIP COVER ALSO HAS VARIOUS MECHANICAL TEARS IN THE VICINITY OF THE HOLES, INCLUDING AT THE EDGE OF THE HOLES. THE PLASTIC SLEEVE HAS TWO CRACKS IN THE AXIAL DIRECTION AT THE PROXIMAL END. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE HOUR INTO A DA VINCI SI HYSTERECTOMY PROCEDURE, ARCING WAS OBSERVED COMING FROM THE TIP COVER ACCESSORY INSTALLED ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE PLANNED 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 8MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10 C11045

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ES