BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIZACT

    MDR report key: 24233649 · Received February 2, 2026

    Report

    Report Number
    1717344-2026-00143
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    December 16, 2025
    Report Date
    February 2, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE INVOLVED DEVICE IS NOT MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES MARKETED DEVICE (BIZACT - GEI). RANDOMIZED CONTROL TRIAL COMPARING TREATMENT OUTCOMES OF MONOPOLAR CAUTERY VERSUS BIZACT¿ TOTAL TONSILLECTOMY IN CHILDREN. TAYLOR LEAVITT, JEFFREY A. CARTER, ANNA H. MESSNER, YI-CHUN LIU, SONAL V. SARAIYA, MATTHEW S. SITTON, KATHLEEN HOSEK, UGOCHUKWU MADUEKE, PAULINA M. POWELL, AND RONALD J. VILELA. INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY 200 (2026) 112689. DATE OF PUBLICATION: 16 DECEMBER 2025 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A STUDY AIMED TO TEST CLAIMS PRESENTED BY MEDTRONIC BY COMPARING OUTCOMES OF BIZACT TONSILLECTOMY WITH MONOPOLAR CAUTERY TONSILLECTOMY IN PEDIATRIC PATIENTS UNDERGOING TONSILLECTOMY. THERE WERE TOTAL OF 144 PATIENTS IN THE STUDY, 71 IN THE BIZACT GROUP AND 73 IN THE MONOPOLAR GROUP. IN THE BIZACT GROUP, THREE PATIENTS RETURNED TO THE EMERGENCY ROOM FOR POSTOPERATIVE PAIN AND DEHYDRATION. FOUR RETURNED FOR POSTOPERATIVE BLEEDING. FOUR PATIENTS REQUIRED REOPERATION WITH REPEAT CAUTERIZATION FOR BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294884 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN BZ4212

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Hospitalization| R