BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS SHUTTLE NEEDLE, BOX OF 5

    MDR report key: 1218697 · Received October 27, 2008

    Report

    Report Number
    1219602-2008-00240
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 7, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVALUATION. CONCLUSION: IMPROPER USE. S&N MANSFIELD QUALITY INDICATES THE COMPLAINT IS BEING ENTERED WITH AN INITIATION DATE OF 08/07/08. COMPLAINT WAS ENTERED AS AN OKC QUALITY RESPONSIBILITY. IT IS A MANUAL OPERATION TO SCAN OKC'S RETURNS FOR POTENTIAL MANSFIELD COMPLAINTS AND THIS WAS INADVERTENTLY MISSED.

    Description of Event or Problem · 1

    SALES REP REPORTED THE TIP OF THE NEEDLES BROKE WHILE INSIDE THE PT. THE SURGEON BELIEVES THE THREE TIPS WERE REMOVED BY FLUSHING, BUT WAS NOT CERTAIN AS THERE WERE NO X-RAYS TAKEN. SALES REP CONCLUDED THAT THE SURGEON WAS TRAPPING THE NEEDLE WHILE CLOSING THE JAW, THEREBY BREAKING THE TIP. SURGEON HAS NOT HAD A PROBLEM SINCE BEING SHOWN THE DEVICES PROPER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE PASS SHUTTLE NEEDLE, BOX OF 5 JACK NEEDLE FMI SMITH & NEPHEW INC., ENDOSCOPY DIV. 7210693 50047647

    Patients

    Seq Age Sex Outcome Treatment
    1