BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP COVER ACCESSORY

    MDR report key: 3905864 · Received July 1, 2014

    Report

    Report Number
    2955842-2014-04007
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED IN THE ORIGINAL SEALED POUCH. MOST LIKELY, THE WRONG ITEM WAS SENT BACK. THE INSTRUMENT ACCESSORY IS DESIGNED AS A SINGLE USE ACCESSORY AND WAS FOUND TO BE UNDAMAGED. WARNING: FAILURE TO INSTALL THE TIP COVER ACCESSORY PROPERLY MAY RESULT IN: IMPROPER SCISSOR OPENING; TIP COVER ACCESSORY FALLING OFF; ELECTRICAL ARCS AND ALTERNATE SITE BURNS THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE MCS TIP COVER ACCESSORY INSTALLED DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE TIP COVER STARTED SLIDING OFF OF THE INSTRUMENT. ACCORDING TO THE CUSTOMER, THE TIP COVER CAN BE TAKEN OFF EASILY BY HAND WITHOUT USE OF THE REMOVAL TOOL. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382744 TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-12 M10140408

    Patients

    Seq Age Sex Outcome Treatment
    1