BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK PENCIL

    MDR report key: 3143133 · Received May 29, 2013

    Report

    Report Number
    1717344-2013-00383
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT. TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. 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 TOTAL HIP REPLACEMENT PROCEDURE, THE TIP PROTECTOR FROM THE ELECTRODE FELL OFF AND COULDN'T BE LOCATED. THE SURGEON WAS USING THE TIP PROTECTOR AS ADDITIONAL INSULATION ON THE ELECTRODE. THE DOCTOR WAS NOT CONCERNED AND BELIEVED THE TIP PROTECTOR WAS SOMEWHERE IN THE DRAPES. THE SURGEON DID ATTEMPT TO LOCATE THE TIP PROTECTOR IN THE WOUND, BUT DIDN'T SEE IT. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION, INCLUDING THE CATALOG NUMBER OR LOT NUMBER OF THE INCIDENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237356 UNK PENCIL UNK COVIDIEN PENCIL GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other