BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTICULATOR 35

    MDR report key: 273739 · Received April 12, 2000

    Report

    Report Number
    1824347-2000-00010
    Event Type
    Other
    Date Received
    April 12, 2000
    Report Date
    March 23, 2000
    Manufacturer
    IMAGYN SURGICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "AEC" BROKE AT THE ARTICULATION JOINT DURING SURGERY. TIP HAD TO BE REMOVED FROM PT. PT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTICULATOR 35 ARTICULATOR 35 GAG IMAGYN SURGICAL 4335 14B00

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other