BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHE CURVED SPATULA TIP

    MDR report key: 5752707 · Received June 27, 2016

    Report

    Report Number
    1717344-2016-00570
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    May 30, 2016
    Report Date
    May 31, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    UDI-DI
    10884524000404
    PMA / PMN Number
    K964175
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. EVALUATION OF THE INCIDENT DEVICE FOUND IT TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. THE INSULATION WAS FOUND TO BE INTACT AND THE DEVICE PASSED HIPOT TESTING INDICATING NO ELECTRICAL LEAKAGE ALONG THE SHAFT. NO CONDITIONS WERE IDENTIFIED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE LAPAROSCOPIC PROCEDURE THERE WAS POWER DISTRIBUTION FROM THE SHAFT OF THE DEVICE. THERMAL SPREAD WAS NOTICED ON THE TISSUE IN CONTACT WITH THE SHAFT. ANOTHER DEVICE WAS OPENED AND IT WORKED FINE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405282 LHE CURVED SPATULA TIP ES ACCESSORY GEI COVIDIEN LP E278128 53620030X 10884524000404

    Patients

    Seq Age Sex Outcome Treatment
    1