BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATION ENT DEV

    MDR report key: 13995285 · Received April 4, 2022

    Report

    Report Number
    3006524618-2022-00148
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    April 1, 2012
    Report Date
    June 6, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4). ARTICLE: LI WUYI, LIU JIANHAN, YANG DAHAI, WANG JIAN, HO HONG, XU CHUNXIAO, ... & GAO ZHIQIANG. (2012). PRELIMINARY EFFECT OF ORAL LOW TEMPERATURE PLASMA-ASSISTED MICROSURGERY IN THE TREATMENT OF HEAD AND NECK TUMORS. MEDICAL JOURNAL OF UNION MEDICAL COLLEGE, 3(2), 143-147.

    Additional Manufacturer Narrative · 0

    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. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. 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 SPECIFICATION UPON RELEASE FOR DISTRIBUTION. 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. PER CASE DETAILS NO FURTHER INFORMATION IS AVAILABLE. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED, AND THE ROOT CAUSE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "INITIAL EFFICACY OF TRANSORAL COBLATION MICROSURGERY FOR HEAD AND NECK TUMORS", AFTER A COBLATION MICROSURGERY USING A EVAC 70 WAND AND A COBLATOR II SURGERY SYSTEM, 2 PATIENTS HAD A SUBCUTANEOUS EMPHYSEMA OF THE NECK, 4 PATIENTS HAD A PHARYNGEAL INCISION CLEFT, WHICH WAS TREATED WITH ORAL CLEANSING AND ANTI-INFLAMMATORIES AND FINALLY THERE WAS 10 PATIENTS WITH ANTERIOR COMMISSURE LARYNGEAL WEB AND GRANULATION, UNKNOWN HOE THIS WAS TREATED. PATIENTS OUTCOME ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498624 UNKN COBLATION ENT DEV ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O