BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER 5MM INSTRUMENT

    MDR report key: 306296 · Received November 21, 2000

    Report

    Report Number
    2936485-2000-00102
    Event Type
    Malfunction
    Date Received
    November 21, 2000
    Date of Event
    November 15, 2000
    Report Date
    November 20, 2000
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CASE THE TIP BROKE. AN X-RAY WAS TAKEN TO MAKE SURE THE TIP WAS RETRIEVED. THERE WAS NO PT INJURY OR DELAY TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER 5MM INSTRUMENT 5MM INSTRUMENT HRX STRYKER ENDOSCOPY 0250-080-234 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *