BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON T2 ICW

    MDR report key: 14541362 · Received May 30, 2022

    Report

    Report Number
    3006524618-2022-00264
    Event Type
    Injury
    Date Received
    May 30, 2022
    Date of Event
    January 1, 2010
    Report Date
    August 23, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470003512
    PMA / PMN Number
    K033584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ARTICLE: SPAHN, G., KLINGER, H. M., MÜCKLEY, T., & HOFMANN, G. O. (2010). FOUR-YEAR RESULTS FROM A RANDOMIZED CONTROLLED STUDY OF KNEE CHONDROPLASTY WITH CONCOMITANT MEDIAL MENISCECTOMY: MECHANICAL DEBRIDEMENT VERSUS RADIOFREQUENCY CHONDROPLASTY. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC & RELATED SURGERY, 26(9), S73-S80.

    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. 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. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. 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. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES PER THE COMPLAINT DETAILS, NO FURTHER INFORMATION IS AVAILABLE. CONSEQUENTLY, WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. 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. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE A FAILURE OF A CONCOMITANT DEVICE. 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 "FOUR-YEAR RESULTS FROM A RANDOMIZED CONTROLLED STUDY OF KNEE CHONDROPLASTY WITH CONCOMITANT MEDIAL MENISCECTOMY: MECHANICAL DEBRIDEMENT VERSUS RADIOFREQUENCY CHONDROPLASTY", 4 PATIENTS HAD PERSISTENT KNEE PROBLEMS AFTER A MENISECTOMY USING A PARAGON WAND, THEREFORE, A REVISION SURGERY WAS REQUIRED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2714521 PARAGON T2 ICW ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. AC5531-01 UNKNOWN 00817470003512

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other