BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COBLATION ENT DEV

    MDR report key: 15643111 · Received October 20, 2022

    Report

    Report Number
    3006524618-2022-00451
    Event Type
    Injury
    Date Received
    October 20, 2022
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ARTICLE: SMITH, N., RILEY, K. O., & WOODWORTH, B. A. (2010). ENDOSCOPIC COBLATOR¿-ASSISTED MANAGEMENT OF ENCEPHALOCELES. THE LARYNGOSCOPE, 120(12), 2535-2539.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE 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, COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. 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 CLINICAL REVIEW STATES THE DATA PRESENTED IN THE AGED ARTICLE DOES NOT PROVIDE INSIGHT OR RELEVANCE TO CURRENT CLINICAL OUTCOMES FOR THE PRODUCT/DEVICE. 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 OF THE ATTACHED IMAGES. THEREFORE, NO FURTHER INTERPRETATION OF THE ATTACHED IMAGES ARE REQUIRED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW ENDOSCOPIC COBLATORTM-ASSISTED MANAGEMENT OF ENCEPHALOCELES, 1 PATIENT HAD AN EPISODE OF MAJOR BLEEDING OCCURRED WHEN AN ANTERIOR ETHMOID ARTERY WAS ENCOUNTERED AND 2 MINOR BLEEDINGS DURING A COBLATION PROCEDURE FOR ENCEPHALOCELES USING A EVAC 70 COBLATION WAND. THE EVENT WAS CONTROLLED WITH THE BIPOLAR FUNCTION ON THE COBLATION DEVICE. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378716 UNKNOWN COBLATION ENT DEV ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| O