BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRETTES & MICROFRA

    MDR report key: 1933119 · Received December 20, 2010

    Report

    Report Number
    1219602-2010-00313
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 23, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING OUR EVALUATION THE FOLLOWING OBSERVATIONS WERE MADE, THE COMPLAINT WAS CONFIRMED THE TIP HAS BEEN BROKEN OFF AND WAS NOT RETURNED. WITHOUT THE RETURN OF THE TIP NO CONCLUSION CAN BE MADE. (B)(4).

    Description of Event or Problem · 1

    DURING ANKLE CASE THE TIP BROKE OFF INTO THE PATIENT; THE DR. HAD TO MAKE A LARGE INCISION TO REMOVE -ADDED 45MIN TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRETTES & MICROFRA FERKEL MICROFRACTURE PICK, 65 LXH SMITH & NEPHEW ENDOSCOPY 72202154 50308595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention