BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 20674024 · Received November 13, 2024

    Report

    Report Number
    3008769756-2024-00034
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 13, 2024
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/13/2024. B3: PUBLICATION YEAR OF 2024. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: SURGICAL MICROWAVE ABLATION OF 397 NEUROENDOCRINE LIVER METASTASES: A RETROSPECTIVE COHORT ANALYSIS OF 16 YEARS OF EXPERIENCE. AUTHOR(S): ALEXANDRA WELLS, VINCENT BUTANO, MICHAEL PHILLIPS, JOSHUA DAVIS, ERIN BAKER, JOHN MARTINIE & DAVID IANNITTI. CITATION: SURGICAL ENDOSCOPY. 2024. IN THIS STUDY, WE CONDUCTED 105 SURGICAL MICROWAVE ABLATIONS AND EXAMINED OUTCOMES RELATED TO SURVIVAL AND LOCAL RECURRENCE. FROM SEPTEMBER 2007 THROUGH DECEMBER 2022, 94 PATIENTS WHO UNDERWENT A SURGICAL MICROWAVE ABLATION WERE INCLUDED IN THE STUDY. A TOTAL OF 105 OPERATIONS WERE PERFORMED WITH 397 TUMORS UNDERGOING MICROWAVE ABLATION. MEDIAN TUMOR SIZE WAS 1.3 CM (RANGE 0.3¿8.0), AND THE MEDIAN NUMBER OF TUMORS ABLATED WAS 2 (RANGE 1¿12). 2.45-GHZ MICRWOWAVE ABLATION SYSTEMS, MULTIPROBE SYSTEMS (NEUWAVE CERTUS, ETHICON ENDO-SURGERY) AND A COMPETITOR 3D IMAGE GUIDANCE TECHNOLOGY (MANUFACTURER: MEDTRONIC EMPRINT SX) WERE USED. REPORTED COMPLICATIONS INCLUDED CLAVIEN¿DINDO GRADE III OR IV COMPLICATIONS (N=9). IN CONCLUSION, SURGICAL MICROWAVE ABLATION OFFERS AN EFFICACIOUS, PARENCHYMAL-SPARING TREATMENT OF HEPATIC METASTASIS OF NET, WITH LOW RATES OF INCOMPLETE ABLATION AND LOCAL RECURRENCE PER TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421352 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention