BEUDAMED
    FDA Adverse Event Other Summary report: N

    MISEAL REPOSABLE THERMAL LIGATING SHEARS

    MDR report key: 3815148 · Received May 7, 2014

    Report

    Report Number
    1223422-2014-00008
    Event Type
    Other
    Date Received
    May 7, 2014
    Date of Event
    March 9, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K122086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE DISTAL PART OF THE INSULATION OF THE JAW BROKE OFF AND FELL INTO THE PATIENT. THE JAW WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276670 MISEAL REPOSABLE THERMAL LIGATING SHEARS ELECTROSURGICAL CUTTING AND COAGULATION GEI MICROLINE SURGICAL, INC. 452-131D 201002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other