BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY 585 SURGICAL LIGHT

    MDR report key: 2963902 · Received February 15, 2013

    Report

    Report Number
    1043572-2013-00014
    Date Received
    February 15, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE LIGHT AND OBTAIN ADDITIONAL INFORMATION. HE FOUND HALF OF THE UPPER/INNER KNUCKLE MISSING FROM THE LIGHT. THE SERVICE TECHNICIAN ALSO NOTICED THAT ANOTHER LIGHT, MOUNTED NEXT TO THE ONE SUBJECT OF THIS EVENT, HAD ALSO SUSTAINED SOME DAMAGE. THE SERVICE TECHNICIAN WAS INFORMED BY THE FACILITY THAT THE UPPER/INNER KNUCKLE OF THE LIGHT FELL OFF WHEN IT WAS HIT BY THE OTHER LIGHT IN THE ROOM DURING REPOSITIONING. THE SERVICE TECHNICIAN REPAIRED THE HARMONY LIGHT BY REPLACING THE DAMAGED KNUCKLE COVERS. THE LIGHT WAS RETURNED TO SERVICE. REFERENCE TO THE OPERATING MANUAL STATES "CAUTION- POSSIBLE EQUIPMENT DAMAGE HAZARD: DO NOT BUMP LIGHTHEADS INTO WALLS OR OTHER EQUIPMENT." AN IN-SERVICE AT THE USER FACILITY WAS PERFORMED ON (B)(6) FOR PROPER OPERATION AND USE OF LIGHT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PIECE OF PLASTIC FELL FROM THE ELBOW PART OF THEIR HARMONY 585 LIGHT DURING A SURGICAL PROCEDURE AND HIT THE SURGEON ON THE HEAD AND LANDED ON HIS SHOULDER. NO PROCEDURAL DELAYS OR CANCELLATIONS REPORTED. NO INJURY TO HOSPITAL STAFF OR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69290 HARMONY 585 SURGICAL LIGHT SURGICAL LIGHT FTD STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other