BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8 MM MCS TIP COVER ACCESSORY

    MDR report key: 2991627 · Received March 6, 2013

    Report

    Report Number
    2955842-2013-00751
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    February 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION RESULTS CONFIRMED THE ISSUE OF MCS TIP COVER ACCESSORY BREAKAGE. THE TIP COVER ACCESSORY WAS RETURNED WITH VARIOUS MECHANICAL TEARS AND A HOLE BURNED THOUGH THE SILICONE. THE SILICONE EXHIBITED LOCALIZED MELTING AROUND THE HOLE WHICH IS INDICATIVE OF ARCING. THE HOLE WAS FOUND TO BE OBLONG, MEASURING ROUGHLY .035 X .020, AND WAS LOCATED ROUGHLY .500 BELOW THE DISTAL END OF THE TIP COVER ACCESSORY. THE EDGE OF THE HOLE HAD A TEAR, AND THERE WERE ALSO VARIOUS TEARS IN THE GENERAL VICINITY OF THE HOLE. AXIALLY ORIENTED TEARS WERE OBSERVED AT THE DISTAL END OPENING OF THE TIP COVER ACCESSORY. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS: INSPECT THE TIP COVER ACCESSORY PERIODICALLY DURING USE. IF ANY DAMAGE OR TEARS ARE OBSERVED, REPLACE THE TIP COVER ACCESSORY WITH A NEW ONE. DO NOT USE ANOTHER INSTRUMENT TO CLEAN THE TIP COVER ACCESSORY. O TO PREVENT DAMAGE TO THE TIP COVER ACCESSORY INSULATION, ALWAYS STRAIGHTEN THE INSTRUMENT WRIST UNDER ENDOSCOPIC VISUALIZATION BEFORE REMOVING THE INSTRUMENT THROUGH THE CANNULA O 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

    IT WAS REPORTED THAT DURING A DA VINCI S LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON NOTICED THAT THE TIP OF THE 8MM MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY USED IN CONJUNCTION WITH THE MCS INSTRUMENT HAD BREAKAGE. ACCORDING TO THE REPORTER, THE SURGICAL STAFF EXCHANGED THE MCS TIP COVER ACCESSORY AND THE PLANNED PROCEDURE WAS COMPLETED. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95568 8 MM MCS TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10 C12090

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURG SYS INST., ACCESSORIES, & ESU