BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPHYRE PROBE II 90 DEG. SUCTION

    MDR report key: 604235 · Received June 30, 2004

    Report

    Report Number
    1216828-2004-00007
    Event Type
    Other
    Date Received
    June 30, 2004
    Date of Event
    June 11, 2004
    Report Date
    June 30, 2004
    Manufacturer
    SMITH & NEPHEW, INC.-ENDOSCOPY DIV
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF A SHOULDER ARTHROSCOPY PROCEDURE, AS THE SURGEON WAS CLOSING THE PT'S INCISION THE PA STEPPED ON THE FOOTPEDAL AND ACTIVATED THE PROBE. THE PROBE HAD BEEN PLACED ALONG THE SIDE OF THE PT'S AXILLA TO PREVENT IT FROM FALLING ON THE FLOOR. THE PT THEN RECEIVED A BURN IN THE AXILLA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other