BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 6945500 · Received October 12, 2017

    Report

    Report Number
    1717344-2017-06046
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Report Date
    November 21, 2017
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    BWA
    UDI-DI
    10884524000381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE WAS REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE OR ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ONE UNIT WAS RETURNED FOR EVALUATION. THE RETURNED SAMPLE DID NOT MEET SPECIFICATION AS RECEIVED. A VISUAL INSPECTION FOUND THE DEVICE WAS MISSING A SPRING. THE INVESTIGATION CONFIRMED THE REPORTED CONDITION. THE INVESTIGATION FOUND THAT THE BIPOLAR FOOT PEDAL WAS MISSING A SPRING WHICH WAS CAUSING A CONTINUOUS ACTIVATION ON THE BIPOLAR FOOT PEDAL AND LEAD TO THE ISSUE WITH THE OTHER PORTS NOT ACTIVATING. THE INVESTIGATION ISOLATED THE FAILURE TO THE MISSING SPRING ON THE BIPOLAR FOOTSWITCH, BUT A ROOT CAUSE WAS NOT IDENTIFIED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS CAUSING THE GENERATOR TO CONTINUOUSLY ACTIVATE. THERE IS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723889 VALLEYLAB UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES BWA COVIDIEN MFG DC BOULDER E6009 243327X 10884524000381

    Patients

    Seq Age Sex Outcome Treatment
    1