BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PK-SP GENERATOR

    MDR report key: 3841084 · Received May 16, 2014

    Report

    Report Number
    2951238-2014-00206
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE PHYSICIAN MADE 3 CUTS AND THE PT STARTED BLEEDING. THE PHYSICIAN ATTEMPTED TO COAGULATE; HOWEVER, THE GENERATOR WAS NOT PRODUCING ENOUGH ENERGY TO STOP THE BLEEDING. AFTER MULTIPLE ATTEMPTS TO TROUBLESHOOT THE GENERATOR, THE PHYSICIAN INSERTED A CATHETER TO CONTROL THE BLEEDING. THE PT WAS UNDER ANESTHESIA FOR 1 1/2 HOURS AND WITH NO BACK UP GENERATOR AVAILABLE THE PROCEDURE WAS STOPPED WITHOUT COMPLETING IT. THE PT CONDITION AFTER THE PROCEDURE WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293334 PK-SP GENERATOR GENERATOR GEI GYRUS ACMI INC. 744000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention