BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2233190 · Received September 2, 2011

    Report

    Report Number
    2955842-2011-00289
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 10, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING FOUND VARIOUS HOLES BURNED THROUGH THE SILICONE. THE SILICONE EXHIBITS LOCALIZED MELTING AROUND THE HOLES, INDICATIVE OF ARCING. THE ULTEM SLEEVE WAS FOUND TO BE MELTED AS ONE HOLE IS LOCATED AT THE INTERFACE BETWEEN THE SILICONE AND ULTEM SLEEVE. THE HOLE SIZES RANGE FROM .140 INCHES TO UNDER .010 INCHES AND ARE LOCATED FROM 0 INCHES TO .300 INCHES ABOVE THE SILICONE TO SLEEVE INTERFACE. THE TIP COVER ACCESSORY WAS ALSO FOUND TO HAVE MECHANICAL TEARS IN THE VICINITY OF THE HOLES, INCLUDING ONE TEAR THAT CONNECTS TWO HOLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, ARCING WAS OBSERVED COMING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH A TIP COVER ACCESSORY INSTALLED. 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 C11136

    Patients

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