BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAST QUADRANT RETRACTOR SYSTEM

    MDR report key: 2509239 · Received March 29, 2012

    Report

    Report Number
    1030489-2012-00376
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Report Date
    April 5, 2012
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    FSZ
    PMA / PMN Number
    K043602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT HAS BEEN IDENTIFIED ON THE RETURNED ITEM THAT CAN BE RESPONSIBLE OF THE EVENT. THE INSTRUCTION FOR USE OF THE DEVICE STATES: "THE RECOMMENDED LIGHT SOURCE UTILIZES 100W LIGHT SOURCES AND 5MM FIBER OPTIC CABLES. USE OF LARGER CABLES AND/OR HIGHER WATTAGE LIGHT SOURCES MAY RESULT IN HIGH TEMPERATURES ON THE METAL CONNECTION TO THE LIGHT CABLE, WHICH MAY RESULT IN INJURY TO PATIENT OR STAFF AND DAMAGE TO PRODUCT. REDUCE INTENSITY LEVELS ON HIGH WATT LIGHT SOURCES/LARGE LIGHT CABLES AND TAKE PRECAUTIONS TO PROTECT PATIENT AND STAFF FROM INJURY." THE OVERHEATING AND THE DAMAGE OF THE DEVICE AS DESCRIBED IN THE EVENT MAY COME FROM THE USE OF INAPPROPRIATE CABLES AND/OR WATTAGE LIGHT SOURCE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING AN UNKNOWN PROCEDURE, THE LIGHT SOURCE OVERHEATED, STOPPED WORKING, AND HAD A SMOKY SMELL." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAST QUADRANT RETRACTOR SYSTEM LIGHT, SURGICAL, CARRIER FSZ WARSAW ORTHOPEDIC, INC. 9560658 0163330W

    Patients

    Seq Age Sex Outcome Treatment
    1