BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 3883882 · Received June 11, 2014

    Report

    Report Number
    1717344-2014-00499
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 A PIECE OF THE ACTIVE BLADE OF THE DEVICE DETACHED AND FELL INTO THE PATIENT DURING A LAPAROSCOPIC HYSTERECTOMY. THE PROCEDURE WAS CONVERTED FROM LAPAROSCOPIC TO AN OPEN PROCEDURE IN ORDER TO RETRIEVE THE MATERIAL FROM THE PATIENT. THE STAFF COULD NOT IMMEDIATELY LOCATE THE PIECE SO THE PATIENT ENDED UP HAVING 3 X-RAYS TO LOCATED IT. THE PROCEDURE WAS EXTENDED BY 5 HOURS. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346103 ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ULTRASONIC REUSABLE GENERATOR- SERIAL # UNKNOWN| ULTRASONIC REUSABLE BATTERY PACK- SERIAL # UNKNOWN