BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE FENESTRATED GRASPER TIP

    MDR report key: 3032578 · Received March 29, 2013

    Report

    Report Number
    1223422-2013-00012
    Event Type
    Other
    Date Received
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K981389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE REF 3222 WITH AN UNKNOWN LOT NUMBER HAVING A BROKEN HINGE WAS RETURNED. THE HINGE OF THE BOTTOM JAW WAS BROKEN. THE FRACTURE OF THE BROKEN HINGE APPEARED TO BE A DUCTILE FRACTURE, WHICH IS CONSISTENT WITH APPLYING EXCESSIVE FORCE.

    Description of Event or Problem · 1

    THE HINGE BROKE INSIDE PT AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130038 DISPOSABLE FENESTRATED GRASPER TIP DISPOSABLE FENESTRATED TIP GEI MICROLINE SURGICAL INC 3222 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1