BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET SAS

    MDR report key: 3297431 · Received August 8, 2013

    Report

    Report Number
    3008355164-2013-00183
    Event Type
    Injury
    Date Received
    August 8, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 10, 2013
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A BREAST SURGERY PROCEDURE, WHILE THE SURGICAL CUPOLA WAS BEING MANIPULATED BY A NURSE, A METAL PART FELL FROM THE LIGHT, THEN THE CUPOLA DETACHED FROM THE SPRING ARM. THE NURSE WAS ABLE TO KEEP THE CUPOLA FROM FALLING BUT REPORTED A BACKACHE AFTER THE EVENT. NO PT INJURIES WERE REPORTED. THE SURGICAL TEAM TRANSFERRED THE PT TO ANOTHER OPERATING ROOM, AND THE SURGERY WAS COMPLETED. (B)(4). REF MFR#: 9710055-2013-00029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375560 MAQUET SAS FSY MAQUET SAS XTEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other