BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE CURRETTE, 17CM OVAL, LG, SPOON 2.2MMX2.5MM

    MDR report key: 3829869 · Received March 11, 2014

    Report

    Report Number
    2951238-2014-00097
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 23, 2014
    Report Date
    February 11, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A MIDDLE EAR SURGERY, TWO CURETTE'S HAD THE CUTTING SIDE OF THE BLADE BREAK OFF. THE PROCEDURE WAS COMPLETED USING AN UNK DEVICE. NO PT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE INFORMATION BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145953 HOUSE CURRETTE, 17CM OVAL, LG, SPOON 2.2MMX2.5MM CURRETTE FZS GYRUS ACMI INC. 272602 03066142/AL

    Patients

    Seq Age Sex Outcome Treatment
    1 2951238-2014-00098.| HOUSE CURETTE, PRODUCT# 272602, LOT #03066142/AL,