BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATION ENT DEV

    MDR report key: 12322395 · Received August 15, 2021

    Report

    Report Number
    3006524618-2021-00841
    Event Type
    Injury
    Date Received
    August 15, 2021
    Date of Event
    December 24, 2013
    Report Date
    October 4, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT REVIEW, AND IFU/DEVICE LABELING REVIEW COULD NOT BE CONDUCTED. 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). ARTICLE: SUNNERGREN O, HEMLIN C, ERICSSON E, HESSÉN-SÖDERMAN AC, HULTCRANTZ E, ODHAGEN E, STALFORS J. RADIOFREQUENCY TONSILLOTOMY IN SWEDEN 2009-2012. EUR ARCH OTORHINOLARYNGOL. 2014 JUN;271(6):1823-7. DOI: 10.1007/S00405-013-2867-4. EPUB 2013 DEC 24. PMID: 24366615.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW ¿RADIOFREQUENCY TONSILLECTOMY IN SWEDEN 2009¿2012¿, AFTER PROCEDURE TWENTY FIVE PATIENTS PRESENTED POST-OPERATIVE INFECTION. THE INFECTIONS WERE TREATED WITH ANTIBIOTICS WITHIN THE FIRST MONTH AFTER SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219735 UNKN COBLATION ENT DEV ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention