BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATOR

    MDR report key: 3181393 · Received May 30, 2013

    Report

    Report Number
    3181393
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 30, 2013
    Manufacturer
    LINVATEC CORPORATION D/B/A CONMED LINVATEC
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE ROUTINE KNEE ARTHROSCOPY, THE GATOR 4.2 MM CURVED SHAVER (PN C9266M) CLOGGED UP AND DID NOT FUNCTION AS IT SHOULD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LEFT KNEE ARTHROSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239926 GATOR ARTHROSCOPE HRX LINVATEC CORPORATION D/B/A CONMED LINVATEC 4.2MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR