BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 19805743 · Received July 23, 2024

    Report

    Report Number
    1717344-2024-01513
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    July 23, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN COOL TI, UNKNOWN COOL TIP ELECRTRODE (LOT#: UNKNOWN) JUXIAN SONG, LI CAO, JIAN CHEN. "LAPAROSCOPIC LIVER RESECTION VERSUS RADIOFREQUENCY ABLATION FOR SMALL HEPATOCELLULAR CARCINOMA: RANDOMIZED CLINICAL TRIAL", 2024 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 RANDOMIZED CLINICAL TRIAL COMPARED PERIOPERATIVE DATA AND LONG-TERM OUTCOMES IN PATIENTS WITH SMALL H EPATOCELLULAR CARCINOMA (HCC) TREATED WITH LAPAROSCOPIC LIVER RESECTION (LLR) OR RADIOFREQUENCY ABLATION (RFA). BETWEEN (B)(6) 2014 TO (B)(6) 2015, THERE WERE 150 PARTICIPANTS WITH 77 PATIENTS WHO RECEIVED LLR AND 73 PATIENTS WHO RECEIVED RFA. COMPLICATIONS OF THE RFA GROUP INCLUDED ATELECTASIS (1), LUNG INJURY (2), HEPATORENAL SYNDROME (1), AND GASTROINTESTINAL PERFORATION (1). ONE PATIENT WHO HAD POSTOPERATIVE COMPLICATIONS OF GASTROINTESTINAL PERFORATION AND LUNG INJURY WAS SUCCESSFULLY TREATED SURGICALLY. LAPAROSCOPIC LIVER RESECTION VERSUS RADIOFREQUENCY ABLATION FOR SMALL HEPATOCELLULAR CARCINOMA: RANDOMIZED CLINICAL TRIAL, JUXIAN SONG, BJS, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480426 UNKNOWN COOL TIP ELECRTRODE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other| R