BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1070036 · Received July 3, 2008

    Report

    Report Number
    2955842-2008-01125
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND MULTIPLE HOLES IN THE SILICONE WITH LOCALIZED MELTING AROUND ALL HOLES THAT IS INDICATIVE OR ARCING. ALL OF THE DAMAGE IS CONTAINED WITHIN ONE HALF OF THE SILICONE, BETWEEN THE TWO PARTING LINES. THE HOLES ARE ALL UNDER .030 INCHES WITH VARYING SHAPES, ROUND AND OBLONG, AND ARE LOCATED FROM .275 INCHES TO .530 INCHES ABOVE THE SILICONE TO SLEEVE INTERFACE. MULTIPLE HOLES INDICATE MULTIPLE ARCING EVENTS OCCURRED. THE TIP COVER ALSO HAS VARIOUS MECHANICAL TEARS IN THE GENERAL VICINITY OF THE HOLES, LIKELY DUE TO INSTRUMENT COLLISIONS OR REPEATED INSTRUMENT WRIST ARTICULATIONS. ENGINEERING CONCLUDED THAT ARCING IS LIKELY DUE TO INSUFFICIENT SILICONE DIELECTRIC STRENGTH, WITH STRENGTH WEAKENED DUE TO INSTRUMENT COLLISIONS. HIGH GENERATOR SETTINGS MAY HAVE ALSO CONTRIBUTED TO ARCING. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TIP COVER ACCESSORY HAS HOLES ON THE SIDE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE FOLLOWING MEDWATCH REPORT WAS SENT TO THE FDA RELATING TO THIS EVENT: 2955842-2008-01126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY GEI INTUITIVE SURGICAL, INC. 400180-05 C7355

    Patients

    Seq Age Sex Outcome Treatment
    1 ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM| MONOPOLAR CURVED SCISSORS| INSTRUMENT