BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVAL PUNCHES

    MDR report key: 1961569 · Received January 14, 2011

    Report

    Report Number
    1219602-2011-00013
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 14, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE OPERATION, THE EDGE OF THE INNER SHAFT WAS BROKEN INSIDE THE JOINT. THE BROKEN PIECE REMAINS IN THE BODY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVAL PUNCHES PCH,OVAL,UPBRT,15D NBH SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7207200 50050778

    Patients

    Seq Age Sex Outcome Treatment
    1