BEUDAMED
    FDA Adverse Event Other Summary report: N

    VULCAN TAC-S ELECTROTHERMAL PROBE

    MDR report key: 291438 · Received August 15, 2000

    Report

    Report Number
    2953127-2000-00012
    Event Type
    Other
    Date Received
    August 15, 2000
    Date of Event
    June 9, 2000
    Report Date
    August 14, 2000
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE TIP DETACHED IN PT'S JOINT DURING SHOULDER ARTHROSCOPY. FRAGMENT WAS SUBSEQUENTLY REMOVED WITHOUT ANY ADD'L INTERVENTION. NO CLINICAL SEQUELAE OR FURTHER COMPLICATIONS ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN TAC-S ELECTROTHERMAL PROBE ELECTROSURGICAL PROBE GEI ORATEC INTERVENTIONS, INC. 911001 041000-06

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other