BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRANT ILLUMINATION SYSTEM

    MDR report key: 3162678 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02155
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 31, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    FTY
    PMA / PMN Number
    K043602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 REVIEW OF THE INSTRUMENT IDENTIFIED ILLUMINATOR LIGHT SOURCE FITTING THAT APPEARED TO BE EXPOSED TO HIGH HEAT, AS EVIDENCE BY DISCOLORATION OF THE OPTICAL FIBERS AT THE FITTING AND MELTING OF BOTH THE EXTERNAL SHEATH AND INTERNAL OPTICAL FIBERS. A QUERY OF THE COMPLAINT DATABASE AS OF (B)(4) 2013 DID NOT IDENTIFY ANY OTHER COMPLAINT WITH RESPECT TO THIS PN/LOT# COMBINATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH EXCEEDING POWER LIMITS OF THE INSTRUMENT DURING USAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, "THE ILLUMINATION SYSTEM CABLE MELTED NEAR THE ACMI SYSTEM. THE TUBING BURNED THROUGH THE STERILE DRAPING OF THE PATIENT AND CAUSED A BLISTER TO THE LEFT SIDE OF THE PATIENT APPROXIMATELY THE SIZE OF A 20 CENT PIECE. THE NURSE APPLIED COMFEEL DRESSING TO THE BLISTERED SITE IMMEDIATELY AFTER SURGERY WAS COMPLETED." NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262561 QUADRANT ILLUMINATION SYSTEM TAPE, MEASURING, RULERS AND CALIPERS FTY WARSAW ORTHOPEDICS 0236048W

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR