BEUDAMED
    FDA Adverse Event Summary report: N

    POLARIS SURGICAL LIGHT

    MDR report key: 3013497 · Received March 20, 2013

    Report

    Report Number
    1043572-2013-00022
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE LIGHT, AND FOUND THE MOUNT WAS LOOSE AND OUT OF LEVEL. ADDITIONALLY, THERE IS POSSIBLE BEARING DAMAGE ON THE MAIN HUB. THE TECHNICIAN ALSO ADJUSTED THE BRAKES. THE TECHNICIAN REPORTED THE LIGHT REMAINS DIFFICULT TO MOVE. THE LIGHT WAS INSTALLED IN 1990, AND IS NOT UNDER STERIS SERVICE CONTRACT. THE POLARIS LIGHT HAS A RECOMMENDED USEFUL LIFE OF 10 YEARS. THE POLARIS SURGICAL LIGHT MAINTENANCE MANUAL CALLS FOR REGULAR CHECKS OF THE CENTRAL HUB, INSPECTION OF THE BRAKES FOR DRIFTING, AND INSPECTION OF THE BRUSHES FOR PROPER OPERATION (SEE PAGE 3-4). THE CAUSE OF THE EVENT WAS BEARING DAMAGE DUE TO EXTENDED USE POST EXPECTED USEFUL LIFE, AND FAILURE BY THE CUSTOMER TO PROPERLY MAINTAIN THE LIGHT. STERIS HAS OFFERED THE HOSPITAL A QUOTE FOR A REPLACEMENT LIGHT. THE HOSPITAL HAS DECLINED TO PROVIDE ANY FURTHER INFORMATION ON THE EVENT, CITING HIPAA CONCERNS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AS A DOCTOR WAS POSITIONING THE LIGHT WITH HIS RIGHT ARM, THE LIGHT "LOCKED UP" AND THE DOCTOR CLAIMS HE RUPTURED HIS BICEPS. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116541 POLARIS SURGICAL LIGHT SURGICAL LIGHT FTD STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1