BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAC-S MICRO VULCAN ANGLED INTEGRATED

    MDR report key: 17942169 · Received October 16, 2023

    Report

    Report Number
    3003604053-2023-00062
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    August 2, 2019
    Report Date
    October 16, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    UDI-DI
    03596010470645
    PMA / PMN Number
    K003198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). ARTICLE: BURN, M. B., SARKISSIAN, E. J., & YAO, J. (2020). LONG-TERM OUTCOMES FOR ARTHROSCOPIC THERMAL TREATMENT FOR SCAPHOLUNATE LIGAMENT INJURIES. JOURNAL OF WRIST SURGERY, 9(01), 022-028. DOI: 10.1055/S-0039-1693973.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE LITERATURE REVIEW "LONG-TERM OUTCOMES FOR ARTHROSCOPIC THERMAL TREATMENT FOR SCAPHOLUNATE LIGAMENT INJURIES"; AFTER ARTHROSCOPIC ELECTROTHERMAL TREATMENT OF LOW-GRADE GEISSLER¿S SCAPHOLUNATE INTEROSSEOUS LIGAMENT (SLIL) INJURIES, USING A VULCAN RF ARTHROSCOPY SYSTEM WITH A MICRO TAC-S ANGLED MONOPOLAR PROBE; 1 PATIENT SUSTAINED AN IPSILATERAL TRIANGULAR FIBROCARTILAGE COMPLEX TEAR THAT REQUIRED TREATMENT. DETAILS ABOUT THE TREATMENT WERE NOT SPECIFIED, AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116870 TAC-S MICRO VULCAN ANGLED INTEGRATED ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC. UNKNOWN 03596010470645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other