BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    33CM LAPAROSCOPIC L-WIRE SPLIT; BLUE PTFE; BLACK INSULATION; PL

    MDR report key: 9859600 · Received March 20, 2020

    Report

    Report Number
    9859600
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    November 14, 2019
    Report Date
    February 12, 2020
    Manufacturer
    XODUS MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC GALLBLADDER REMOVAL, THE MD WAS USING THE SURGICAL PENCIL WHEN HE SAW A SPARK IN THE BELLY. UPON REMOVING THE SURGICAL PENCIL FROM THE ABDOMEN, HE COULD SEE THAT A SMALL PIECE OF THE INSULATION AROUND THE TIP WAS MISSING, AND MELTED FLAKES OF INSULATION COULD BE SEEN ON THE LIVER. THE SURGICAL PENCIL WAS AT THE 30/30 SETTING WHICH IS THE MINIMUM IT CAN BE AT. FOR SOME REASON, THEY FELT THE SPARK WAS FROM THE INSULATION. THEY GOT ANOTHER SURGICAL PENCIL TO FINISH THE CASE. PER THE RN, "DURING LAPAROSCOPIC CASE, SURGICAL PENCIL SPARKED FROM INSULATION, MELTED INSULATION FLAKES LEFT ON LIVER. SURGICAL PENCIL SETTING 30 COAG, 30 CUT, PURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322267 33CM LAPAROSCOPIC L-WIRE SPLIT; BLUE PTFE; BLACK INSULATION; PL ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI XODUS MEDICAL, INC. 20115SPI 18DEC26

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA