BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 2981120 · Received February 4, 2013

    Report

    Report Number
    2936485-2013-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    PMA / PMN Number
    K954726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 DURING A PROCEDURE, FOREIGN MATERIAL WAS FOUND WITHIN THE PACKAGE. IT WAS FURTHER REPORTED THAT A BACKUP UNIT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45775 STRYKEFLOW2 WITHOUT TIP (6BX) GCX STRYKER ENDOSCOPY 12286FG2

    Patients

    Seq Age Sex Outcome Treatment
    1