BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT SWITCHING LAPAROSCOPIC CORD

    MDR report key: 3944308 · Received May 8, 2014

    Report

    Report Number
    1717344-2014-00405
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE PROCEDURE, THE DOCTOR INDICATED THAT THE COAGULATION DID NOT FUNCTION VERY WELL. IT WAS THEN NOTICED THAT THE FOOT SWITCHING LAPAROSCOPIC CORD WAS ON FIRE. THE CORD WAS COMPLETELY BURNED THROUGH. A NEW CORD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278021 FOOT SWITCHING LAPAROSCOPIC CORD ES ACCESSORY GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCE FX GENERATOR, SN (B)(4)