BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES

    MDR report key: 3162164 · Received May 31, 2013

    Report

    Report Number
    1423253-2013-00003
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
    Product Code
    KPS
    PMA / PMN Number
    K992731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED MODEL NUMBERS: 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823946, 07823953, 07823979, 10151531, 10151532, 10275879, 10413009, 10520745, 10275007, 10275008, 10275009, 10275010. THERE ARE FOUR (4) APPLICABLE 510(K): SYMBIA E SINGLE/DUAL: K072567, K082506; SYMBIA S AND T SERIES: K082506. RESULT CODE: AN END CAP FELL OFF AND EXPOSED A SHARP EDGE. THIS IS NOT A FAILURE OF THE DEVICE. THE END CAPS ARE DESIGNED TO COME OFF SO THAT SERVICE CAN ACCESS THE LIGHT RAIL FOR THE DETECTOR. A MISSING END CAP IS A SERVICE CALL AND THE SERVICE ENGINEER CAN REPLACE THEM. THE USERS MAY ALSO HAVE THEIR SERVICE ENGINEER ORDER EXTRA END CAPS FOR THEM TO KEEP ON HAND AND REPLACE THEMSELVES IF THEY SHOULD FALL OFF.

    Description of Event or Problem · 1

    A NUCLEAR MEDICINE GAMMA CAMERA DETECTOR LIGHT RAIL END CAP HAD FALLEN OFF THE LIGHT RAIL. A SHARP EDGE WAS EXPOSED WITHOUT THE END CAP. THE END CAP IS DESIGNED FOR REMOVAL SO THAT A SERVICE TECHNICIAN CAN ACCESS THE LIGHT RAIL. A TECHNOLOGIST (OPERATOR) WAS INJURED WHEN SHE REACHED IN THE GANTRY AREA TO REMOVE A BLANKET FROM A PT. WHEN THE TECHNOLOGIST PULLED THE BLANKET AND HER ARM OUT OF THE GANTRY AREA, SHE PULLED HER ARM ALONG THE SHARP EDGE AND CUT HER FOREARM. THE CUT REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240570 E.CAM, SYMBIA E, SYMBIA S, SYMBIA T SERIES GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP A4380213

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other