BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE SEMI RIGID FORCEP

    MDR report key: 3896046 · Received May 20, 2014

    Report

    Report Number
    2951238-2014-00207
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. WHEN EVALUATION IS COMPLETED THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A HYSTEROSCOPY WITH DILATION AND CURETTAGE, THE JAW BROKE OFF INSIDE THE PATIENT. THE JAW THAT BROKE OFF WAS RETRIEVED WITH NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299396 SLIMLINE SEMI RIGID FORCEP GRASPER FORCEP HIH GYRUS ACMI INC. GYA-5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1