BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 1172707 · Received September 18, 2008

    Report

    Report Number
    2648666-2008-00106
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Report Date
    September 3, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP BROKE OFF DURING PROCEDURE, BUT WAS RECOVERED CLEANLY FROM THE PATIENT. ANOTHER SUPER 90-S WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERFAS ENERGY SUPER 90-S PROBE GEI STRYKER ENDOSCOPY PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK