BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE PASS DISPOSABL

    MDR report key: 1980458 · Received February 7, 2011

    Report

    Report Number
    1219602-2011-00021
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Report Date
    December 30, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE
    Product Code
    HWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AFTER FINISHED THE SHOULDER ARTHROSCOPY, THE SURGEON FIND A SHADOW IN X-RAY WITH THE SHARP LIKE BROKEN TIP OF "ELITE PASS SHUTTLE NEEDLE" (PRODUCT CODE #7210693), AS THE DEVICE IS NOT ON HAND. THE SURGEON WAS NOT SURE WHETHER THE SHADOW IS BROKEN NEEDLE OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE PASS DISPOSABL SUTURE NEEDLE SHUTTLE STERILE HWQ SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE 7210693 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1