BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.4MM MICRO SCISSOR PUNCH

    MDR report key: 1911340 · Received November 23, 2010

    Report

    Report Number
    2936485-2010-00875
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE OF THE UNIT WAS LOST AND LEFT IN THE PT DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.4MM MICRO SCISSOR PUNCH SCISSOR HRX STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR