BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER 90-S 3.5MM

    MDR report key: 3840206 · Received May 23, 2014

    Report

    Report Number
    MW5036335
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 19, 2014
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, SURGEON WAS JABBING INSTRUMENT IN RIGHT SHOULDER AND THE TIP OF THE INSTRUMENT BROKE OFF. X-RAY WAS TAKEN TO LOCATE TIP AND REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307122 SUPER 90-S 3.5MM SUPER 90-S HRX STRYKER ENDOSCOPY 279-351-300 13240AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other