BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX SYSTEM

    MDR report key: 2966043 · Received February 17, 2013

    Report

    Report Number
    1030489-2013-00526
    Event Type
    Malfunction
    Date Received
    February 17, 2013
    Date of Event
    February 7, 2013
    Report Date
    July 24, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    FSZ
    PMA / PMN Number
    K993021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL AND OPTICAL EXAMINATION OF THE RETURNED INSTRUMENT IDENTIFIED APPEARANCE OF PLASTIC OPTICAL FIBER STRANDS MELTED, CONSISTENT WITH EXCEEDING POWER LIMITS DURING USAGE, PER THE CAUTION LABEL ON THE OUTSIDE OF THE INSTRUMENT PACKAGING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH INAPPROPRIATE USAGE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT SOURCE CAUGHT ON FIRE DURING A MICRODISCECTOMY. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69900 METRX SYSTEM LIGHT, SURGICAL, CARRIER FSZ WARSAW ORTHOPEDICS 0222865W

    Patients

    Seq Age Sex Outcome Treatment
    1