BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ARTHROWAND AND CONTROLLER

    MDR report key: 15452060 · Received September 19, 2022

    Report

    Report Number
    3006524618-2022-00413
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    October 1, 2010
    Report Date
    April 26, 2023
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: SUI HAIJING, XIAO SHUIFANG, QIN YONG, WANG QUANGUI, ZHAO ENMIN, LIU YUHE, ... & CONG TIECHUAN. (2010). CLINICAL STUDY OF POSTOPERATIVE BLEEDING IN PLASMA RF-ASSISTED OPALOPHARYNGOPLASTY. CHINESE JOURNAL OF OTOLARYNGOLOGY HEAD AND NECK SURGERY, 45(10 ), 830-834.

    Additional Manufacturer Narrative · 0

    H10 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A COMPLAINT HISTORY REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS AN INSTRUCTION FOR USE REVIEW COULD NOT BE CONDUCTED. 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 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; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. 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 "STUDY ON HEMORRHAGE FOLLOWING COBLATION ASSISTED UVULOPALATOPHARYNGOPLASTY", 1 PATIENT HAD A BLEEDING(UNKNOWN IF PRIMARY OR SECONDARY) AFTER AN UVULOPALATOPHARYNGOPLASTY PROCEDURE USING A EVAC 70 COBLATION WAND. THE EVENT WAS TREATED/RESOLVED BY OR TREATMENT NEEDING BLOOD TRANSFUSION AND CAUTERIZATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680779 UNKN ARTHROWAND AND CONTROLLER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H