BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE E-SEP

    MDR report key: 17602539 · Received August 23, 2023

    Report

    Report Number
    17602539
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    August 15, 2023
    Report Date
    August 16, 2023
    Manufacturer
    STRYKER CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS WAS A LEEP PROCEDURE. A STRYKER LOOP T-BAR ELECTRODE W20 D15 L120, REF: 0703-320-015, LOT: 2230013, EXP: 2025-07-17 WAS USED. THE ELECTRODE BROKE DURING THE PROCEDURE. THE SURGEON CONFIRMED NOTHING BROKE OFF INSIDE THE PATIENT. A DIFFERENT ELECTRODE WAS THEN USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496685 NEPTUNE E-SEP ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER CORPORATION 0703-320-015 2230013

    Patients

    Seq Age Sex Outcome Treatment
    1 12045 DA Female