BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSPAN SYSTEM

    MDR report key: 735577 · Received July 15, 2005

    Report

    Report Number
    2210968-2005-00428
    Event Type
    Malfunction
    Date Received
    July 15, 2005
    Report Date
    June 22, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    FED
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 7/15/2005. H-6: CONCLUSION CODE 67: THE PRODUCT UPON WHICH THIS METWATCH IS BASED IS ANTICIPATED.

    Description of Event or Problem · 1

    DURING A HYSTEROSCOPY, A PIECE OF PLASTIC FROM THE SHEATH BECAME DETACHED AND HAD TO BE REMOVED FROM THE UTERINE CAVITY WITH GRASPERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSPAN SYSTEM SHEATH FED ETHICON, INC. NA 041210-805

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN