BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPES ASPIRATING ABLATOR

    MDR report key: 1911587 · Received October 27, 2010

    Report

    Report Number
    1911587
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ARTHREX, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING DIAGNOSTIC ARTHROSCOPY OF THE LEFT KNEE. ARTHREX OPES ASPIRATING ABLATOR ABRUPTLY STOPPED WORKING. A REPLACEMENT ABLATOR WAS OBTAINED (SAME MANUFACTURER AND ITEM NUMBER). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REPLACEMENT DEVICE. NO ADVERSE EVENT OCCURRED AND NO PATIENT COMPLICATIONS SECONDARY TO DEVICE FAILURE. THERE WAS A SLIGHT DELAY IN FINISHING THE PROCEDURE WHILE THE REPLACEMENT PRODUCT WAS OBTAINED FROM STOCK.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE FAILURE DUE TO UNKNOWN CAUSE.====================== MANUFACTURER RESPONSE FOR ARTHROSCOPIC ASPIRATING ABLATOR, ARTHREX OPES ASPPIRATING ABLATOR======================MANUFACTURER WILL SEND CALL TAG TO HAVE PRODUCT PICKED UP. PRODUCT IS AWAITING PICK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPES ASPIRATING ABLATOR ARTHROSCOPIC ASPIRATING ABLATOR GEI ARTHREX, INC * 373771
    2 OPES ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI ARTHREX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR