BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS

    MDR report key: 2061778 · Received March 31, 2011

    Report

    Report Number
    2061778
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, A PIECE OF THE MARYLAND BIPOLAR ENDOWRIST BROKE OFF INSIDE PATIENT. BROKEN PIECE OF DEVICE WAS RETRIEVED BY DOCTOR (MD). ENTIRE DEVICE WAS INSPECTED AND THEN TAKEN OUT OF OPERATING ROOM (OR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS ENDOWRIST BIPOLAR CAUTERY INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420172 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *