BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NICOLET

    MDR report key: 169732 · Received May 29, 1998

    Report

    Report Number
    169732
    Event Type
    Malfunction
    Date Received
    May 29, 1998
    Date of Event
    May 27, 1998
    Report Date
    May 28, 1998
    Manufacturer
    NICOLET BIOMEDICAL INC
    Product Code
    JXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER CASE WHEN REMOVING THE 55EP PROBE FROM THE NECK A PIECE OF THE PROBE BROKE OFF REMAINING IN THE PT'S NECK - IT WAS REMOVED BY THE SURGEON WITH HEMOSTAT (SO NO REMAINING PIECES WERE LEFT IN THE PT.) STAFF ASKED SURGEON IF STAFF NEEDED TO SAVE PIECE AND HE SAID NO, SO PIECE DISPOSED OF IN SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICOLET 55EP PROBE (NEEDLE) JXE NICOLET BIOMEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other