BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPHYRE PROBE II 90 DEG. SUCTION

    MDR report key: 708441 · Received May 3, 2006

    Report

    Report Number
    1216828-2006-00024
    Event Type
    Other
    Date Received
    May 3, 2006
    Date of Event
    February 6, 2006
    Report Date
    April 28, 2006
    Manufacturer
    SMITH & NEPHEW, INC.-ENDOSCOPY DIVISION
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT CAME IN FOR A FOLLOW-UP AND HAD A BURN ON THE MEDIAL PORTION OF THE OPERATIVE SIDE ELBOW. IT IS NOT CERTAIN WHAT IT WAS CAUSED BY. ONLY TWO ITEMS IN THE FIELD THAT COULD CAUSE THIS ARE THE VALLEY LAB BOVIE PAD AND THE SAPHYRE PROBE. NO OTHER INFORMATION IS AVAILABLE FOR THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other