BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM DIAMOND BURR

    MDR report key: 2479209 · Received February 24, 2012

    Report

    Report Number
    1037007-2012-00002
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 24, 2012
    Manufacturer
    GYRUS ENT LLC
    Product Code
    EQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AS OF (B)(4), 2012. NO ACTUAL INJURY REPORTED. NO OTHER COMPLAINTS ON FILE FOR THIS PART NUMBER IN 2 YEARS.

    Description of Event or Problem · 1

    BURR TIP BROKE OFF DURING SURGERY. THE BURR TIP CAME OFF AND MIGRATED TO THE ESOPHAGUS. THE SURGEONS AND EMERGENCY DOCTORS DECIDED TO ALLOW IT TO PASS INTO THE STOMACH TO BE ELIMINATED NATURALLY. NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3MM DIAMOND BURR EQJ GYRUS ENT LLC 0342955133

    Patients

    Seq Age Sex Outcome Treatment
    1 Other