BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAC-S MICRO VULCAN ANGLED INTEGRATED

    MDR report key: 17942342 · Received October 16, 2023

    Report

    Report Number
    3003604053-2023-00063
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    August 2, 2019
    Report Date
    November 17, 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). 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.

    Additional Manufacturer Narrative · 0

    H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THAT THERE WERE NO CLINICAL FACTORS FOUND WHICH WOULD HAVE DEFINITIVELY CONTRIBUTED TO THE EVENT. THE CLINICAL ROOT CAUSE OF THE REPORTED (¿1 PATIENT SUSTAINED A CONTRALATERAL DISTAL RADIUS FRACTURE IN SUBSEQUENT FALLS THAT REQUIRED TREATMENT¿) BEYOND THAT WHICH IS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED. THE PATIENT IMPACT BEYOND THE REPORTED CANNOT BE DETERMINED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. H11: H2: CORRECTED DATA ON H6 (HEALTH EFFECT - CLINICAL CODE).

    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 A CONTRALATERAL DISTAL RADIUS FRACTURE IN SUBSEQUENT FALLS 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
    1285318 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