BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1221485 · Received November 3, 2008

    Report

    Report Number
    2955842-2008-01346
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 31, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY HAS BEEN DISCARDED AT THE SITE, AND WILL NOT BE RETURNED FOR EVALUATION, HOWEVER, THE MONOPOLAR CURVED SCISSORS INSTRUMENT USED DURING THE PROCEDURE WAS RETURNED FOR ANALYSIS. PER THE CUSTOMER REPORTED COMPLAINT, THE INSTRUMENT WAS VISUALLY INSPECTED AT THE DISTAL END FOR SIGNS OF ARCING. A .040 INCH BY .060 INCH CHAR MARK WAS FOUND BELOW ONE EAR, ON THE LOWER PORTION OF THE PROXIMAL CLEVIS. THE CHAR MARK IS LIKELY AN AREA WHERE ENERGY ESCAPED THROUGH THE TIP COVER. THE CHAR MARK IS LOCATED NEAR OR JUST SLIGHTLY ABOVE THE SILICONE TO SLEEVE INTERFACE ON THE TIP COVER ACCESSORY. THE INSTRUMENT DOES NOT HAVE ANY BURRS OR DAMAGE IN THE AREA OF THE CHAR MARKS THAT WOULD HAVE CONTRIBUTED TO ARCING. ENGINEERING CONCLUDED THAT ARCING MAY HAVE OCCURRED DUE TO HIGH GENERATOR SETTINGS OR DAMAGE TO THE TIP COVER SILICONE. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    ON OCTOBER 6, 2008, MEDWATCH UF / IMPORTER REPORT WAS RECEIVED: WHILE SETTING UP FOR THE CASE, THE PROTECTIVE COVER WAS PLACED PROPERLY ON THE MONOPOLAR SCISSORS, AND INSPECTED PRIOR TO THE CASE. SCISSORS WERE MOUNTED ON ROBOT ARM, ROBOT SIGNALED INSTRUMENT WAS OK AND READY TO USE. SCISSORS WERE IN USE WHEN A CHARRED AREA ON THE PROTECTIVE COVER BETWEEN THE CLEAR AND COLORED AREA ON THE SLEEVE WAS NOTICED. THE SCISSORS WERE TAKEN OUT OF SERVICE IMMEDIATELY. DURING CLEANING PROCESS, THE PROTECTIVE SLEEVE WAS THROWN AWAY (IT'S A DISPOSAL PART THE SET-UP). THIS IS A REUSABLE INSTRUMENT THAT HAS 10 LIVES. IT HAD 2 LIVES REMAINING OUT OF THE 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420179-08 0804281 249

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR DA VINCI S SURGICAL SYSTEM| AN ELECTROSURGICAL UNIT| TIP COVER ACCESSORY