BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LHE CURVED SPATULA TIP

    MDR report key: 5505288 · Received March 16, 2016

    Report

    Report Number
    1717344-2016-00246
    Event Type
    Injury
    Date Received
    March 16, 2016
    Date of Event
    December 28, 2015
    Report Date
    February 19, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. EVALUATION OF THE INCIDENT ELECTRODE CONFIRMED THE SPATULA TIP HAD DISENGAGED. THE ELECTRODE BROKE AT THE NARROWEST POINT AND HAD AN UNEVEN BREAK. THE MANUFACTURING PROCESS WAS REVIEWED AND NOTHING WAS IDENTIFIED IN THE PROCESS THAT WOULD CAUSE METAL FATIGUE. THE ROOT CAUSE OF THE BROKEN TIP COULD NOT BE DETERMINED. REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT CONFIRMED THE PRODUCT WAS RELEASED MEETING ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AFTER REMOVING A MASS IN THE PATIENT'S OVARY, THE IRRIGATION PROCESS WAS STARTED. THEN THE DOCTOR NOTICED THAT THE ELECTRODE TIP HAD FALLEN INSIDE THE PATIENT. THE PRESENCE OF THE TIP OF THE ELECTRODE WAS CONFIRMED BY RADIOGRAPHY IN THE ABDOMINAL AREA AND THEY PROCEEDED TO PERFORM AN EXPLORATORY TO REMOVE THE TIP AND INSPECT THE INTESTINE. THE PATIENT IS IN GOOD HEALTH CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160602 LHE CURVED SPATULA TIP ES ACCESSORY GEI COVIDIEN LP E278128 51790081X

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention