BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKS CUTTING FORCEPS

    MDR report key: 2062809 · Received April 11, 2011

    Report

    Report Number
    2062809
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 11, 2011
    Manufacturer
    GYRUS ACMI, AN OLYMPUS COMPANY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUTTING FORCEPS WOULD NOT WORK DURING CASE, EVEN AFTER CHANGING CORDS. SURGEON SWITCHED TO ANOTHER BRAND TO DO THE PROCEDURE. NO HARM TO THE PATIENT OR STAFF DUE TO THE MALFUNCTION. NO PATIENT INFO PROVIDED TO RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS CUTTING FORCEPS CUTTING FORCEPS GEI GYRUS ACMI, AN OLYMPUS COMPANY * 261568MC

    Patients

    Seq Age Sex Outcome Treatment
    1 *