BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1874374 · Received October 19, 2010

    Report

    Report Number
    2955842-2010-00444
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 22, 2010
    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. THE SILICONE HAS A .055 LONG TEAR THROUGH THE ENTIRE WALL THICKNESS, LOCATED APPROXIMATELY .270 ABOVE THE INTERFACE WITH THE SLEEVE. THE SILICONE DOES NOT HAVE MELTING AROUND THE TEAR. THE OUTER SURFACE OF THE SILICONE ALSO EXHIBITS A COUPLE OF SCRATCHES/GOUGES ON THE OPPOSITE SIDE OF THE TEAR, LOCATED APPROXIMATELY .045 ABOVE THE SILICONE TO SLEEVE INTERFACE. NO EVIDENCE OF ARCING WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT AND TIP COVER ACCESSORY WERE NOT RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT AND/OR TIP COVER ACCESSORY ARE RETURNED (POST-EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE ARCING WAS OBSERVED THROUGH THE SIDE OF THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON THE MCS INSTRUMENT. THE TIP COVER WAS IMMEDIATELY REMOVED AND REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. 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 C10179

    Patients

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