BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA EVO EXCEL

    MDR report key: 8936082 · Received August 27, 2019

    Report

    Report Number
    1423253-2019-00006
    Event Type
    Injury
    Date Received
    August 27, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 12, 2019
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    KPS
    PMA / PMN Number
    K162337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED OF A SERVICE ENGINEER INJURY ON (B)(6) 2019. A SERVICE ENGINEER NEGLECTED TO FOLLOW PROCEDURE 8738010-VFT-000-07 WHEN SERVICING A SYMBIA EVO EXCEL GAMMA CAMERA AT A CUSTOMER SITE. AS A RESULT, THE ENGINEER RECEIVED INJURIES TO HIS FINGER WHILE TESTING SYSTEM MOTION. HIS FINGER WAS PINCHED BETWEEN MOVING COMPONENTS. THE INJURED SERVICE ENGINEER HAD SURGERY ON HIS MIDDLE FINGER, LEFT HAND. THE LAST PHALANX (BONE OF THE FINGER) WAS RECONSTRUCTED BY THE SURGEONS. THERE ARE NO PRODUCT OR LABELING DEFICIENCIES OR MALFUNCTION. THERE WAS NO OTHER INJURY TO ANY OTHER PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728391 SYMBIA EVO EXCEL GAMMA CAMERA KPS SIEMENS MEDICAL SOLUTIONS USA, INC. 10910501

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention