BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIZACT

    MDR report key: 19393372 · Received May 24, 2024

    Report

    Report Number
    1717344-2024-01217
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 25, 2024
    Report Date
    June 26, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:B5, G3, H6 (RFR: DEVICE STOPPED WORKING) 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: VLFT10GEN FT SERIES ENERGY PLATFORMX1 (SERIAL#: UNKNOWN) THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K171066. 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 REPORTER, DURING TONSILECTOMY PROCEDURE, THE SURGEON COMPLAINED THAT TOO MUCH BLEEDING WAS OBSERVED AND COMPLAINED THAT THE DEVICE DID NOT SEAL COMPLETE. THERE WAS ACTIVATION TONE BUT ALARM END TONES WERE NOT HEARD. NO BLOOD TRANSFUSION WAS PERFORMED AND NO MEDICAL INTERVENTION OR REOPERATION DONE TO PATIENT TO STOP THE BLEEDING. THE PROCEDURE WAS COMPLETED BY A NON-MEDTRONIC SUCTION COAGULATION DEVICE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING TONSILECTOMY PROCEDURE, THE SURGEON COMPLAINED THAT TOO MUCH BLEEDING WAS OBSERVED AND COMPLAINED THAT THE DEVICE DID NOT SEAL COMPLETE AND ALARM END TONES WERE NOT HEARD. NO BLOOD TRANSFUSION WAS PERFORMED AND NO MEDICAL INTERVENTION OR REOPERATION DONE TO PATIENT TO STOP THE BLEEDING. THE PROCEDURE COMPLETED A NON-MEDTRONIC SUCTION COAGULATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299373 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER BZ4212 23140113X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE NOTE ON H11