BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 1903578 · Received November 16, 2010

    Report

    Report Number
    2648666-2010-00456
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE PRODUCT/LOT NUMBER COMBINATION WAS REVIEWED. THERE WERE NO DISCREPANCIES OBSERVED THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE NONCONFORMANCE HISTORY OF THE PRODUCT/PART NUMBER COMBINATION WAS REVIEWED. NO DISCREPANCIES WERE NOTED RELATIVE TO THE REPORTED FAILURE MODE. A PROCESS ASSESSMENT WAS PERFORMED AND THE CONTRIBUTING FACTORS THAT MAY HAVE LED TO THE REPORTED FAILURE MODE INCLUDE THE FOLLOWING: BLUE BUTTON FLAG DAMAGE UPON INSERTION DURING ASSEMBLY; BLUE BUTTON DAMAGE DURING ASSEMBLY; MISSING SPRING; DEFECTIVE SPRING; A FAULT IN THE ELECTRICAL CONNECTION(S). IN SUM, THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WORKED WITHOUT PUSHING THE IRRIGATION AND SUCTION BUTTONS. IT WAS FURTHER REPORTED THAT THE SURGEON STOPPED USING THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) SUCTION/IRRIGATION GCX STRYKER ENDOSCOPY PUERTO RICO 10243FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK