BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE SEMI-REGID FORCEPS

    MDR report key: 3802398 · Received February 21, 2014

    Report

    Report Number
    2951238-2014-00066
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Report Date
    January 30, 2014
    Manufacturer
    GYRUS ACMI INC
    Product Code
    HIN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. IF ADD'L INFO OR IF THE DEVICE IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE, THE JAW AT THE TIP OF THE FORCEP BROKE OFF AND FELL INTO THE PT. THE JAW WAS RETRIEVED FROM THE PT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109983 SLIMLINE SEMI-REGID FORCEPS SEMI-RIGID ALLIGATOR FORCEPS HIN GYRUS ACMI INC GYA-5 2165

    Patients

    Seq Age Sex Outcome Treatment
    1