BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 1911356 · Received November 23, 2010

    Report

    Report Number
    2648666-2010-00465
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 10, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS DISCARDED AND THE REPORTED FAILURE COULD NOT BE EVALUATED OR CONFIRMED. THE MOST PROBABLE CAUSES FOR THE REPORTED FAILURE ARE LACK OF SOLVENT DURING ASSEMBLY AND THAT THE TUBE WAS CUT TOO SHORT. DEVICE HISTORICAL DATA SHOWED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED FAILURE IS THAT THE TUBE WAS CUT TOO SHORT. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED AS THE DEVICE WAS DISCARDED. THE REPORTED FAILURE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FLUID WAS LEAKING FROM THE PUMP BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) STRYKEFLOW GCX STRYKER ENDOSCOPY PUERTO RICO 10181FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK