BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM

    MDR report key: 2840187 · Received November 14, 2012

    Report

    Report Number
    3004365956-2012-00327
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    TELEFLEX
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER PROVIDED WAS NOT A VALID LOT NUMBER. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING THAT THE RUSCH GREENSPEC FO HANDLE IS OVERHEATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH GREENSPEC FIBEROPTIC HANDLE, MEDIUM GREENSPEC FIBEROPTIC HANDLE CCW TELEFLEX 104501

    Patients

    Seq Age Sex Outcome Treatment
    1