BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATOR II SURGERY SYSTEM AND WAND

    MDR report key: 12478789 · Received September 15, 2021

    Report

    Report Number
    3006524618-2021-00912
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    April 28, 2019
    Report Date
    October 20, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K142999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. THE INSTRUCTIONS FOR USE WAS 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. THE DATA PRESENTED IN THIS ARTICLE REPORTED, ONE PATIENT DEVELOPED NASAL SEPTAL ABSCESS AND NASAL PAIN. THE PATIENT REQUIRED ANTIBIOTICS (AMOXICILLIN AND LEVOFLOXACIN). PER THE COMPLAINT, NO FURTHER INFORMATION IS AVAILABLE FOR THIS LITERATURE CASE. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED. IN ADDITION, THE PHYSICIAN REFERENCED IN THE ABSTRACT PROVIDED AN ANALYSIS OF ALL THE ATTACHED IMAGES. THEREFORE, NO FURTHER INTERPRETATION OF THE ATTACHED IMAGES IS REQUIRED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. 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. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4). KIM, T., KIM, J. S., & HEO, S. J. (2019). NASAL SEPTAL ABSCESS DEVELOPED AFTER RADIOFREQUENCY CAUTERIZATION FOR EPISTAXIS. JOURNAL OF CRANIOFACIAL SURGERY, 30(8), E713-E714. DOI: DOI: 10.1097/SCS.0000000000005687.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW ¿NASAL SEPTAL ABSCESS DEVELOPED AFTER RADIOFREQUENCY CAUTERIZATION FOR EPISTAXIS.¿, AFTER SURGERY WITH EVAC 70 WAND, ONE PATIENT DEVELOPED NASAL SEPTAL ABSCESS AND NASAL PAIN. THE PATIENT REQUIRED ANTIBIOTICS (AMOXICILLIN AND LEVOFLOXACIN). NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375483 UNKN COBLATOR II SURGERY SYSTEM AND WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention