BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMO SURE HIGH FLOW INSUFFLATOR

    MDR report key: 1689222 · Received April 29, 2010

    Report

    Report Number
    2936485-2010-00354
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VESSEL HARVEST, THE INSUFFLATORS WOULD NOT HOLD PRESSURE IN THE LEG, THEREFORE, PREVENTING VISUALIZATION OF THE SITE. IT WAS FURTHER REPORTED THAT THE TUBING WAS SWITCHED, WHICH HELPED TEMPORARILY. HOWEVER, THE PROBLEM OCCURRED AGAIN. IT WAS FURTHER REPORTED THAT THE INSUFFLATORS WERE SWITCHED, WHICH FIXED THE PROBLEM. THE CASE WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMO SURE HIGH FLOW INSUFFLATOR INSUFFLATOR FCX STRYKER ENDOSCOPY SAN JOSE 0808CE273

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK