BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDU EP-1 HND CNTRL

    MDR report key: 374088 · Received January 24, 2002

    Report

    Report Number
    1643264-2002-00005
    Event Type
    Malfunction
    Date Received
    January 24, 2002
    Report Date
    January 3, 2002
    Manufacturer
    SMITH & NEPHEW, INC.-ENDOSCOPY DIV
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PRIOR TO A SURGERY BEGINING, THIS HANDPIECE WAS PLUGGED IN AND AFTER AN UNSPECIFIED PERIOD OF TIME, THE HANDPIECE BECAME EXCESSAVILY HOT TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDU EP-1 HND CNTRL ENDOSCOPIC SHAVER HANDPIECE NBH SMITH & NEPHEW, INC.-ENDOSCOPY DIV 7205354 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA