BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPHYRE PROBE II 90 DEG. SUCTION

    MDR report key: 775125 · Received October 30, 2006

    Report

    Report Number
    1216828-2006-00046
    Event Type
    Other
    Date Received
    October 30, 2006
    Date of Event
    September 29, 2006
    Report Date
    October 29, 2006
    Manufacturer
    SMITH & NEPHEW, INC. - ENDOSCOPY DIV
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROBE HAS NOT BEEN RETURNED FOR EVAL THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    BURN NEXT TO PORTAL. CUSTOMER STATES PROBE FELT WARM IN COAG MODE. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPHYRE PROBE II 90 DEG. SUCTION PROBE GEI SMITH & NEPHEW, INC. - ENDOSCOPY DIV 7210111 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other