BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2131904 · Received June 16, 2011

    Report

    Report Number
    2955842-2011-00177
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED TWO HOLES BURNED THOUGH THE SILICONE. THE SILICONE EXHIBITS LOCALIZED MELTING AROUND THE HOLE WHICH IS INDICATIVE OF AN ARCING EVENT. THE HOLE SIZES ARE .055 AND .045 X .075 WITH VARYING SHAPES (ROUND AND OBLONG), AND ARE LOCATED .075 AND .320 ABOVE THE SILICONE TO SLEEVE INTERFACE. AN ADDITIONAL INVESTIGATION IS BEING CONDUCTED TO DETERMINE ROOT CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, TWO HOLES WERE OBSERVED TO HAVE BEEN BURNED IN THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER ACCESSORY INSTALLED ON THE MONOPOLAR CURVED SCISSORS INSTRUMENT. NO ARCING WAS OBSERVED. 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. 400180-10 C11038

    Patients

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