BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 3063740 · Received April 17, 2013

    Report

    Report Number
    0002936485-2013-00149
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCX
    PMA / PMN Number
    K954726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS RETURNED. HOWEVER, THE HOLE IN THE PACKAGE WAS CAUSED BY IMPROPER HANDLING OR SHIPPING. THE STERILE FIELD WAS NOT BROKEN. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A HOLE IN THE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A HOLE IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164507 STRYKEFLOW2 WITHOUT TIP (6BX) APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX STRYKER ENDOSCOPY-SAN JOSE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1