BEUDAMED
    FDA Adverse Event Summary report: N

    VLED HARMONY LIGHTS

    MDR report key: 2883686 · Received December 21, 2012

    Report

    Report Number
    1043572-2012-00103
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FST
    PMA / PMN Number
    K100395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS SERVICE TECHNICIAN INSPECTED THE SPRING ARM OF THE LIGHT AND NOTED THAT IT APPEARED THAT THE SNAP RING WASN'T SNAPPED INTO PLACE. THE LIGHTHEAD WAS FOUND TO BE OPERATING PROPERLY. THE TECHNICIAN REPLACED THE SPRING ARM AND RETURNED THE UNIT TO SERVICE. THE SPRING ARM WAS RETURNED TO STERIS QUALITY FOR EVALUATION. NO ANOMALIES WERE OBSERVED IN THE SNAP RING, GROVE ON THE SPINDLE NECK OR IN THE ORIENTATION OF WHERE THE SNAP RING WAS LOCATED WHEN IT WAS RETURNED LOCKED IN THE GROOVE OF THE SPINDLE. DURING EVALUATION THE ARM WAS MOUNTED WITH A VLED LIGHTHEAD. THE LIGHTHEAD WAS ROTATED AND BOUNCED TO ITS HIGHEST POINT IN THE UP POSITION WHICH IS THE ONLY LOCATION THAT COULD HAVE ALLOWED PRESSURE TO COME OFF OF THE SPINDLE AND ALLOW IT TO DROP DOWN IF THE SNAP RING WAS NOT IN PLACE. THESE TESTS WERE PERFORMED SEVERAL TIMES WITHOUT ISSUES. ADDITIONAL TESTING WAS PERFORMED BY ADDING ADDITIONAL WEIGHT; NO ISSUES WERE NOTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE WAS TRYING TO POSITION THE SURGICAL LIGHT BEFORE A PATIENT PROCEDURE AND THE LIGHTHEAD CAME LOOSE AT THE BOOM ELBOW AND FELL TO THE FLOOR. THE EMPLOYEE THAT WAS POSITIONING THE LIGHTHEAD REPORTED THAT SHE STRAINED HER BACK. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED AND THE EMPLOYEE MISSED NO TIME FROM WORK. NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VLED HARMONY LIGHTS SURGICAL LIGHTS FST STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1