BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LHE CURVED SPATULA TIP

    MDR report key: 5490151 · Received March 9, 2016

    Report

    Report Number
    1717344-2016-00228
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    December 28, 2015
    Report Date
    February 12, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 03/10/2016. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE TIP OF THE CURVED SPATULA ELECTRODE BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE DISENGAGED PIECE WAS IDENTIFIED IN THE PATIENT'S ABDOMINAL CAVITY BY RADIOLOGIC SEARCH AND WAS RETRIEVED IMMEDIATELY BY THE SURGEON THROUGH AN EXPLORATORY LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145236 LHE CURVED SPATULA TIP ES ACCESSORY GEI COVIDIEN LP E278128 51790081X

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention