BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE STAPES CURETTE, STRONG

    MDR report key: 1902963 · Received October 28, 2010

    Report

    Report Number
    1423507-2010-00043
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 27, 2010
    Manufacturer
    CAREFUSION
    Product Code
    JYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE EFFECTED INSTRUMENT WAS NOT RECEIVED FOR EVALUATION. THE COMPLETE INSTRUMENT IS CRUCIAL FOR A COMPLETE AND ACCURATE ANALYSIS OF THE CONCERN. A METALLURGICAL REVIEW OF THE PORTION RECEIVED SHOWS THAT THE INSTRUMENT HAD BEEN STRUCTURALLY DAMAGED PREVIOUS TO THIS USE AND SHOULD HAVE BEEN TAKEN OUT OF SERVICE. IT IS NOT POSSIBLE TO SAY WHAT CAUSED THE PREVIOUS DAMAGE AS IT MAY HAVE BEEN DUE TO ONE OF THE FOLLOWING: NORMAL WEAR, MISUSED OR EVEN BEING DROPPED DURING A SIMPLE CLEANING PROCESS. THE INSTRUMENT SEGMENT PROVIDED MEETS ALL APPLICABLE SPECIFICATIONS THAT WOULD INDICATE THAT THE FAILURE IS NOT DUE TO WORKMANSHIP OR MATERIALS. A REVIEW OF TRENDS OVER 10 YEARS AND DEVICE HISTORY HAS REVEALED NO PREVIOUS INCIDENTS OF ANY NATURE. THE RESULT OF THIS INVESTIGATION IS COMPLETE AT THIS TIME. DUE TO THE FINDINGS OF THIS INVESTIGATION, A CORRECTIVE AND PREVENTIVE ACTION WILL NOT BE INITIATED.

    Description of Event or Problem · 1

    BROKEN TIP CUSTOMER STATES THE CUP END OF THE INSTRUMENT FELL IN THE WOUND. THE PIECE WAS RETRIEVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE STAPES CURETTE, STRONG NA / JYG JYG CAREFUSION AU12452 A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention