BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR PK WORKING ELEMENT

    MDR report key: 3940221 · Received June 19, 2014

    Report

    Report Number
    2951238-2014-00244
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINE. IF ADD'L INFO IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE USER RECEIVED A SHOCK WHILE USING THE WORKING ELEMENT TO PERFORM THE COAGULATION FUNCTION OF THE DEVICE WITH A SP GENERATOR. NO PT INJURY WAS REPORTED. IT IS UNK IF THE PROCEDURE WAS COMPLETED. OLYMPUS ATTEMPTED MULTIPLE TIMES TO F/U WITH THE USER FACILITY, HOWEVER, NO FURTHER INFO WAS OBTAINED. IF NEW INFO IS RECEIVED AT A LATER DATE THIS REPORT WILL BE SUPPLEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359471 BIPOLAR PK WORKING ELEMENT WORKING ELEMENT FDC GYRUS ACMI INC EIWE-BRPK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) SP GENERATOR, 2951238-2014-00242