BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUCKBILL

    MDR report key: 1950972 · Received January 6, 2011

    Report

    Report Number
    1219602-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE SHOWS THE INNER TIP IS MISSING AND WAS NOT RETURNED FOR EVALUATION. THE CUTTING EDGE IS DENTED AND DULL. A PORTION OF THE ACTUATOR LUG IS MISSING. THE CONDITION OF THE CUTTING EDGE WOULD REQUIRE EXCESSIVE FORCE BE APPLIED TO CUT. AS REPORTED DEVICE WAS PURCHASED IN 2002 AND REPAIRED THE LAST TIME IN 2006. DEVICE IS IN NEED OR REFURBISHMENT/MAINTENANCE AND MOST LIKELY DID AT THE TIME OF THIS EVENT.(B)(4)

    Description of Event or Problem · 1

    THE DUCKBILL BROKE DURING THE SURGERY AND THE SURGEON HAD TO OPEN THE KNEE TO REMOVE THE BROKEN PIECE (OPEN ON 4 CM); BUT THE INCIDENT OCCURRED AT THE END OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUCKBILL PCH,BSKT,DCKBL,UPBTR,1.5MM NBH SMITH & NEPHEW ENDOSCOPY 012014 L602

    Patients

    Seq Age Sex Outcome Treatment
    1