BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED

    MDR report key: 2211259 · Received July 12, 2011

    Report

    Report Number
    2936485-2011-00491
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT'S PRESSURE IS FLUCTUATING UP AND DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED ARTHROSCOPY PUMP HRX STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK