BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH TRULED RECHARGEABLE HANDLE SET

    MDR report key: 4180353 · Received October 15, 2014

    Report

    Report Number
    1044475-2014-00281
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 29, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE SIZE 3 MILLER BLADE IS STUCK ON THE HANDLE AND CANNOT BE REMOVED. THE ALLEGED DEFECT OCCURRED AFTER CLEANING NAD REPROCESSING. THERE WAS NO REPORT OF PT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654017 RUSCH TRULED RECHARGEABLE HANDLE SET LAYRNGOSCOPE HANDLE GCI TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1