BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PENCIL

    MDR report key: 11120518 · Received January 5, 2021

    Report

    Report Number
    1717344-2021-00014
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    October 23, 2020
    Report Date
    January 5, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EVALUATION OF ULTRASONIC AXILLARY DISSECTION IN PRESERVATION OF INTERCOSTOBRACHIAL NERVE AND LYMPHATIC SEALING IN BREAST CANCER PATIENTS: RANDOMIZED CONTROLLED TRIAL SOURCE: ANNALS OF MEDICINE AND SURGERY 60 (2020) 255¿260 AVAILABLE ONLINE 1 NOVEMBER 2020, 2049-0801/© 2020 THE AUTHORS. PUBLISHED BY ELSEVIER LTD ON BEHALF OF IJS PUBLISHING GROUP LTD. (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY ANALYZED POST-OPERATIVE COMPLICATIONS IN 40 PATIENTS WHO UNDERWENT BREAST SURGERY FOR BREAST CANCER BETWEEN JANUARY 2017 AND SEPTEMBER 2019. THE HARMONIC SCALPEL WAS USED FOR AXILLARY LYMPH NODE DISSECTION (ALNS) IN 20 PATIENTS AND ELECTROCAUTERY WAS USED ALNS IN 20 PATIENTS. IN ALL PATIENTS, ELECTROCAUTERY WAS USED TO CREATE THE SKIN FLAPS AND SEPARATE THE BREAST TOGETHER WITH PECTORAL FASCIA FROM THE UNDERLYING PECTORALIS MAJOR MUSCLE. POST-OPERATIVE COMPLICATIONS IN PATIENTS WHO UNDERWENT ALNS WITH ELECTROCAUTERY WERE: HEMATOMA, SEROMA, WOUND INFECTION AND AXILLARY NUMBNESS. INTERVENTIONS FOR THE COMPLICATIONS WERE NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14506 UNKNOWN PENCIL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN PENCIL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention