BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGHT CORD

    MDR report key: 5229068 · Received November 10, 2015

    Report

    Report Number
    MW5057863
    Event Type
    Death
    Date Received
    November 10, 2015
    Date of Event
    August 31, 2015
    Report Date
    November 10, 2015
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    STRYKER ENDOSCOPY LIGHT CORD, MODEL 00233050064, DOES NO INCLUDE ANY TYPE OF SAFETY INTERLOCK THAT WILL PREVENT THE LIGHT SOURCE FROM BEING ACTIVATED WITHOUT A SCOPE ATTACHED. REASON FOR USE: HYSTEROSCOPY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744409 LIGHT CORD LIGHT CORD FCW STRYKER ENDOSCOPY 00233050064

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R| S