BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAGENER EAR HOOK, 2.5 X150

    MDR report key: 4940399 · Received July 24, 2015

    Report

    Report Number
    2951238-2015-00327
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    May 27, 2015
    Report Date
    May 28, 2015
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THE DISTAL END HOOK PORTION OF THE DEVICE WAS BROKEN OFF. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINE AS THE BROKEN PORTION WAS NOT RETURNED. THIS TYPE OF TIP DAMAGE IS MOST LIKELY DUE TO HEAVY STRESS APPLIED AT THE DISTAL END CAUSING THE HOOK BASE JOINT TO BEND, CRACK AND EVENTUALLY BREAK OFF.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER 123602. IF ADDITIONAL OR SIGNIFICANT INFORMATION IS AVAILABLE AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE TIP BROKE OFF AND FELL INTO THE PATIENT. THE DEVICE FRAGMENT WAS RETRIEVED WITH ALLIGATOR FORCEPS. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT BY TELEPHONE AND IN WRITING BUT WITH NO RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484602 WAGENER EAR HOOK, 2.5 X150 WAGENER EAR HOOK LRC GYRUS ACMI INC. 123602 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1