BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN CAUTERY DEVICE IN DBD-ABD HYSTERECTOMY CDS

    MDR report key: 7654363 · Received July 2, 2018

    Report

    Report Number
    1423395-2018-00034
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    May 1, 2018
    Report Date
    July 2, 2018
    Manufacturer
    MEDTRONIC (COVIDIEN)
    Product Code
    OJF
    UDI-DI
    10889942497355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING AN UNIDENTIFIED PROCEDURE, THE "CAUTERY TIP IGNITED DURING USE." AFTER MULTIPLE GOOD-FAITH ATTEMPTS, THE CUSTOMER WAS UNABLE OR UNWILLING TO PROVIDE ADDITIONAL PATIENT, PRODUCT, OR PROCEDURAL INFORMATION RELATED TO THIS INCIDENT. NO SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE WAS ORIGINALLY REPORTED. NO IMPACT TO A PATIENT, A PATIENT'S STABILITY, A PATIENT'S PLAN OF CARE, OR TO THE UNIDENTIFIED PROCEDURE WAS ORIGINALLY REPORTED. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNIDENTIFIED PROCEDURE, THE "CAUTERY TIP IGNITED DURING USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499334 COVIDIEN CAUTERY DEVICE IN DBD-ABD HYSTERECTOMY CDS OJF MEDTRONIC (COVIDIEN) 17VB3343 10889942497355

    Patients

    Seq Age Sex Outcome Treatment
    1 Other