BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAPHYRE II, 60 DEG

    MDR report key: 664754 · Received January 13, 2006

    Report

    Report Number
    1216828-2006-00005
    Event Type
    Other
    Date Received
    January 13, 2006
    Date of Event
    December 15, 2005
    Report Date
    January 12, 2006
    Manufacturer
    SMITH & NEPHEW, INC.- ENDOSCOPY DIV
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE PROBE BECAME TOO HOT FOR THE SURGEON TO HANDLE. IT WAS STATED THAT THE SURGEON IS SOMEONE WHO LIKES TO ACTIVATE THE PROBE FOR AN EXTENDED TIME BUT NO ESTIMATE OF THAT TIME WAS GIVEN. CONTACT FOR THE FACILITY ALSO INDICATED THAT SHE WAS TOLD THAT THE PT WAS BURNED WHEN THE TIP OF THE PROBE MELTED. UNK HOW PT WAS TREATED FOR THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAPHYRE II, 60 DEG PROBE GEI SMITH & NEPHEW, INC.- ENDOSCOPY DIV 7210113 600166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other