BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLED

    MDR report key: 3533924 · Received December 18, 2013

    Report

    Report Number
    9710055-2013-00058
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 19, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL BIOMED ADVISED MAQUET THAT HE INSPECTED THE HANDLE AND THE LIGHT AND HE BELIEVES THAT THERE IS NO ISSUE WITH THE DEVICE. THE BIOMED ATTEMPTED TO PULL THE HANDLE OFF THE LIGHT AS HARD AS HE COULD WITHOUT PRESSING THE RELEASE BUTTONS WITH NO SUCCESS. THE BIOMED STATED THAT THE SURGEON REFUSES TO ALLOW ANYONE ELSE TO MOUNT THE HANDLE TO THE LIGHT AND BELIEVES THE SURGEON FAILED TO ATTACH THE HANDLE CORRECTLY. THE HANDLE AND LIGHT WERE INSPECTED BY THE MAQUET SERVICE ENGINEER, AND WERE FOUND IN PERFECT WORKING CONDITION. THE MAQUET HELD OPERATING MANUAL PROVIDES INDICATIONS TO USERS IN ORDER TO VERIFY THAT HANDLE CLICKS INTO PLACE PRIOR TO USE. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE HOSPITAL BIOMED REPORTED TO A MAQUET SERVICE ENGINEER THAT A HELD STERILISABLE HANDLE FELL OFF THE LIGHT HEAD AND STRUCK A PATIENT ON THE NOSE. PATIENT SUFFERED A SMALL CUT ON THE NOSE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661050 HLED NA FSY MAQUET SAS HLED300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other