BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 6965495 · Received October 20, 2017

    Report

    Report Number
    2134265-2017-10066
    Event Type
    Injury
    Date Received
    October 20, 2017
    Report Date
    September 22, 2017
    Manufacturer
    STELLARTECH RESEARCH CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CHEN. X JAMES, ET AL, "COMPLICATION AND READMISSION RATES FOLLOWING SAME-DAY DISCHARGE AFTER PERCUTANEOUS RENAL TUMOR ABLATION¿, JOURNAL VASCULAR INTERVENTION RADIOLOGY(2016) 27:80¿86. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    BRAND NAME UPDATED FROM BARD® RF ABLATION GENERATOR TO RF3000 RADIOFREQUENCY GENERATOR. UPN- SEARCH: UPDATED (B)(4). MANUFACTURER NAME UPDATED FROM BOSTON SCIENTIFIC - (B)(4). MFG SITE NAME: (B)(4).

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENTS EXPERIENCED COMPLICATIONS POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES. IMMEDIATE PROCEDURAL COMPLICATIONS AFTER RFA PROCEDURE WERE REPORTED AS HEMORRHAGE, PNEUMOTHORAX, HEMATOMA, NEUROPATHY, RESPIRATORY DISTRESS.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED VIA JOURNAL ARTICLE THAT PATIENTS EXPERIENCED COMPLICATIONS POST RADIOFREQUENCY ABLATION (RFA) PROCEDURES. IMMEDIATE PROCEDURAL COMPLICATIONS AFTER RFA PROCEDURE WERE REPORTED AS HEMORRHAGE, PNEUMOTHORAX, HEMATOMA, NEUROPATHY, RESPIRATORY DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746088 RF3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STELLARTECH RESEARCH CORPORATION UNK372

    Patients

    Seq Age Sex Outcome Treatment
    1 Other