BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOOP HANDLE BASKET PUNCH

    MDR report key: 1594327 · Received January 29, 2010

    Report

    Report Number
    1219602-2010-00029
    Event Type
    Malfunction
    Date Received
    January 29, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 31, 2009
    Manufacturer
    MANSFIELD MANUFACTURING
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS NOT RETURNED THE DEVICE FOR EVALUATION. (B) (4)

    Description of Event or Problem · 1

    THE USER INDICATED THAT DURING THE OPERATION, HE FOUND SOMETHING LIKE BROWN OIL RELEASED FROM THE BITE TIP UNDER SCOPE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOOP HANDLE BASKET PUNCH LOOP HANDLE BASKET PUNCH/NBH NBH MANSFIELD MANUFACTURING 010912 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1