BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE EZC ELECTROSURGICAL GENERATOR

    MDR report key: 2370043 · Received November 10, 2011

    Report

    Report Number
    1717344-2011-01040
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 8, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT GENERATOR HAS NOT BEEN RECEIVED FOR EVAL. IF THE UNIT IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLONOSCOPY, THE GENERATOR PROVIDED AN ACTIVATION TONE BEFORE THE FOOTPEDAL IN USE WAS DEPRESSED. THE CUSTOMER REPORTED THAT AN UNK TYPE OF COVIDIEN PAD WAS IN USE WHEN THE ACTIVATION TONE WAS HEARD AND THAT THE GENERATOR MADE AN ALARM INDICATING THE SURGICAL STAFF TO CHECK THE PAD. THERE WAS NO PT INJURY. ANOTHER GENERATOR WAS BROUGHT IN AND USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE EZC ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK E6008| COVIDIEN FOOTSWITCH: SERIAL# (B)(4)| BOSTON SCIENTIFIC SNARE: SERIAL #UNK| UNK COVIDIEN RETURN ELECTRODE: SERIAL #UNK