BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1960584 · Received January 13, 2011

    Report

    Report Number
    2955842-2011-00012
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ARCING PROBLEM. THE DA VINCI SYSTEM WAS FOUND TO BE WITHIN SPECIFICATION AND THE ESU SETTINGS USED DURING THE PROCEDURE WERE WITHIN THE ISI RECOMMENDED RANGE. DIFFERENT MCS INSTRUMENTS AND TIP COVER ACCESSORIES WERE USED DURING THE PROCEDURE AND THESE ITEMS WERE UNAVAILABLE DURING FSE'S SITE VISIT. THE TIP COVER ACCESSORIES HAVE BEEN DISCARDED BY THE SITE AND MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS ARE NOT AVAILABLE FOR RETURN, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AS OF (B)(4) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL. THE FOLLOWING MEDWATCH MFR REPORTS WERE SUBMITTED TO THE FDA IN REGARDING THESE EVENTS: 2955842-2011-00013 AND 2955842-2011-00014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED, ARCING WAS OBSERVED. THE MCS INSTRUMENT AND TIP COVER WERE REMOVED AND REPLACED, AND THE PROCEDURE CONTINUED AS PLANNED. AFTER AN UNSPECIFIED AMOUNT OF TIME, THE REPLACEMENT MCS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED WAS OBSERVED TO HAVE ARCED. THE MCS INSTRUMENT AND TIP COVER WERE REMOVED, THE MCS INSTRUMENT WAS INSPECTED AND FOUND TO HAVE NO DAMAGE AND THEREFORE ONLY THE TIP COVER WAS REPLACED. THE SURGICAL PROCEDURE RESUMED AS PLANNED. A SHORT TIME LATER, THE SURGICAL STAFF WITNESSED ARCING FROM THE MCS INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED. THE MCS INSTRUMENT AND TIP COVER WERE REMOVED A THIRD TIME AND THE TIP COVER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH THE FOURTH REPLACEMENT TIP COVER ACCESSORY 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

    Patients

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