BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR

    MDR report key: 3780649 · Received April 18, 2014

    Report

    Report Number
    2951238-2014-00182
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 10, 2014
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVAL. WHEN EVAL RESULTS ARE COMPLETED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THIS GENERATOR WAS BEING USED WITH CUTTING FORCEPS THAT WOULD NOT COAGULATE. A SECOND DEVICE WAS OPENED AND WOULD ALSO NOT COAGULATE. PT INJURY WAS REPORTED; HOWEVER, THE CUSTOMER WOULD NOT PROVIDE DETAILS AS TO THE EVENT OF THE INJURY. THE PROCEDURE WAS NOT COMPLETED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO BUT NO FURTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238646 GENERATOR GENERATOR GEI GYRUS ACMI, INC. G400 20722026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention REG #2951238-2014-00181| PKS CUTTING FORCEPS: 92005PK| PKS CUTTING FORCEPS: 92005PK,| REG #2951238-2014-00180