BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHTO TUBE SET

    MDR report key: 2150259 · Received June 30, 2011

    Report

    Report Number
    2150259
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    THE CIRCULATING NURSE ATTACHED THE SUCTION IRRIGATION UP TO THE MACHINE. THE PRESSURE OF THE FLUID COMING OUT WAS LOW EVEN THOUGH THE PUMP PRESSURE ON THE MACHINE WAS HIGH. SHE TRIED A SECOND IRRIGATING PUMP MACHINE AND THE PRESSURE OF THE FLUID COMING OUT WAS LOW EVEN WHEN THE MACHINE WAS ON HIGH. THE CIRCULATING NURSE SWITCHED TO A NEW TUBING AND ATTACHED IT TO THE MACHINE. THE FLOW OF THE FLUID COMING OUT OF THE NEW TUBING WAS HIGH. THE SECOND TUBING WORKED APPROPRIATELY.======================MANUFACTURER RESPONSE FOR SUCTION / IRRIGATION, AHTO TUBE SET (PER SITE REPORTER)======================WILL PICKUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AHTO TUBE SET SUCTION / IRRIGATION GCX STRYKER ENDOSCOPY 250-070-620 11021FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR