BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEM MARYLAND DISSECTOR INSERT - 5MM, REUSA

    MDR report key: 296466 · Received September 11, 2000

    Report

    Report Number
    1722040-2000-00007
    Event Type
    Malfunction
    Date Received
    September 11, 2000
    Date of Event
    August 10, 2000
    Report Date
    September 11, 2000
    Manufacturer
    ENCISION INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED JAW OF MARYLAND DISSECTOR BROKE OFF IN PT. ALL PARTS WERE RETRIEVED. NO INJURY TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM MARYLAND DISSECTOR INSERT - 5MM, REUSA LAPAROSCOPIC ELECTROSURGICAL INSTRUMENT COMPONENT KNS ENCISION INC. ES00003 CF

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other