BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE E-PROBE 5MM X 32CM L-TIP PROBE PACKAGIN

    MDR report key: 2063305 · Received April 11, 2011

    Report

    Report Number
    2648666-2011-00101
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE PROBE MELTED THE DISTAL OUTER SHEATH OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE E-PROBE 5MM X 32CM L-TIP PROBE PACKAGIN PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 11034FE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK