BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE CANNULAS -

    MDR report key: 1780011 · Received August 2, 2010

    Report

    Report Number
    1219602-2010-00205
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 2, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE DEVICE HAS NOT BEEN RECEIVED FROM THE CUSTOMER FOR EVALUATION.(B) (4)

    Description of Event or Problem · 1

    DURING THE SURGERY, THE VALVE BROKE OFF. NOT SURE IF IT WENT INTO PATIENT OR ON THE FLOOR. SEVERAL ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION, BUT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE CANNULAS - CANNULA,5.8,HIFLO,ROT,DIAG NBH SMITH & NEPHEW ENDOSCOPY 3869 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1