BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RE-NEW FORCEP LAPAROSCOPIC SURGICAL TIPS

    MDR report key: 3912087 · Received May 14, 2014

    Report

    Report Number
    1223422-2014-00010
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MICROLINE SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K974066
    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, ONE OF THE GRASPER JAWS BROKE OFF AND FELL INTO THE PATIENT. THE JAW WAS REMOVED FROM THE PATIENT. NO ONE WAS HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287891 RE-NEW FORCEP LAPAROSCOPIC SURGICAL TIPS MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL, INC. 3222 00115501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other