BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE

    MDR report key: 12463451 · Received September 13, 2021

    Report

    Report Number
    3014527682-2021-00016
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 24, 2021
    Report Date
    September 10, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    UDI-DI
    10884524002217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUTERY DEVICE CONTAINED IN THIS REPORT IS NOT MANUFACTURED BY ROI CPS, LLC. THE DEVICE IS PURCHASED AND USED AS A COMPONENT WITHIN CUSTOM PROCEDURE KITS MANUFACTURED BY ROI CPS, LLC.

    Description of Event or Problem · 0

    THE CAUTERY PENCIL WAS WORKING IMPROPERLY AND THE TIP WAS TO HOT TO USE. THERE WAS PATIENT CONTACT BUT NO HARM TO THE PATIENT. NO DELAY TO THE CASE. ANOTHER CAUTERY WAS PULLED FROM STERILE STOCK AND USED FOR THE PROCEDURE. THE CAUTERY PENCIL IS A COMPONENT CONTAINED WITHIN A CUSTOM PROCEDURE KIT BUILT BY ROI CPS, LLC. KIT 880030015, LOT 891190.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360866 EDGE ROCKER SWITCH PENCIL, BLADE ELECTRODE, HOLSTER GEI COVIDIEN LP E2350HGNSB 203350344R 10884524002217

    Patients

    Seq Age Sex Outcome Treatment
    1