BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO BOBBIN VT 1.27 MM TI

    MDR report key: 5056837 · Received September 4, 2015

    Report

    Report Number
    1037007-2015-00006
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 6, 2015
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ETD
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE METAL VENT TUBE DROPPING METAL SHAVINGS WAS NOT CONFIRMED AS THE REVIEW OF THE RETURNED BOBBIN VENT TUBE, IT WAS FOUND THERE TO BE NO METALS SHAVINGS AROUND THE OURTER DIAMETER OF THE SHAFT. THIS PART IS MANUFACTURED IN (B)(4) FACILITY AND PACKAGED INTO THE FINISHED GOOD AT THE (B)(4) FACILITY. CURRENT INVENTORY WITHIN THE FOUR WALLS OF EACH FACILITY IS BEING HELD AND INVESTIGATED. THE COMPLAINT HISTORY REPORT WAS REVIEWED AND NO TRENDING WAS OBSERVED FOR THIS OCCURENCE. FAILURE MODE HAS NOT OCCURRED FREQUENTLY ENOUGH TO REQUIRE CORRECTIVE ACTION. FURTHER INVESTIGATION IS OCCURING TO DETERMINE IF FURTHER CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON NOTICED THE SHAVINGS FROM THE MACHINING PROCESS WERE ABOUT TO FALL OFF THE VENT TUBE. NOTHING FELL INTO THE PATIENT, AND NO INJURIES REPORTED. TWO DEVICES WERE USED IN THIS CASE, SEE MFR REPORT # 1037007-2015-00005 FOR FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587189 MICRO BOBBIN VT 1.27 MM TI MICRO BOBBIN ETD GYRUS ACMI, INC. 145781 IH892762

    Patients

    Seq Age Sex Outcome Treatment
    1