BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARION INSTRUMENTS THERMAL LIGATING SHEARS

    MDR report key: 3772145 · Received April 11, 2014

    Report

    Report Number
    1223422-2014-00007
    Event Type
    Other
    Date Received
    April 11, 2014
    Date of Event
    March 7, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MICROLINE SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K062257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE THE THERMAL LIGATING SHEAR SILICONE TIP PEELED AND FELL INTO THE PT. THE BROKEN PIECES WERE REMOVE AND THE PT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221604 STARION INSTRUMENTS THERMAL LIGATING SHEARS ELECTROSURGICAL CUTTING AND COAGULATION GEI MICROLINE SURGICAL INC. 132-136D 208007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other