BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH GREENSPEC FIBEROPTIC HANDLE MEDIUM

    MDR report key: 2043083 · Received February 23, 2011

    Report

    Report Number
    3004365956-2011-00069
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EQN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN RECEIVED BY MANUFACTURER, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: HANDLE BECOMES EXTREMELY HOT TO THE POINT THAT THE CARE GIVERS ARE UNABLE TO HOLD THEM. THE HANDLES ARE ALSO MELTING THE BATTERIES. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH GREENSPEC FIBEROPTIC HANDLE MEDIUM GREENSPEC FIBEROPTIC HANDLE EQN TELEFLEX MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1