BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPHYRE II, 60 DEG

    MDR report key: 1051304 · Received May 22, 2008

    Report

    Report Number
    1216828-2008-00003
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 30, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    AFTER THE PROCEDURE, A MINOR BURN OF ABOUT 5MM X 6CM WAS NOTED ON THE SKIN NEAR THE SCOPE INSERTION SITE. ANOTHER SCOPE WAS USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPHYRE II, 60 DEG PROBE GEI SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7210113

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK