BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 1066417 · Received June 26, 2008

    Report

    Report Number
    1717344-2008-00297
    Event Type
    Injury
    Date Received
    June 26, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 30, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE REPORTED THEY WILL HAVE A 3RD PARTY EVALUATION OF THE PENCIL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED OR THE RESULTS OR THE 3RD PARTY EVALUATION IS RELEASED TO COVIDIEN, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT AT FIRST THE ELECTROSURGICAL PENCIL (WHICH THE SITE BELIEVES IS A COVIDIEN LP PRODUCT) WOULD NOT ACTIVATE. DURING THE ATTEMPTS TO DISCOVER IF IT WAS THE GENERATOR OR PENCIL THAT WAS THE PROBLEM, THE PENCIL WAS LAID ON PT AGAINST A CLAMP AND DEVICE SELF-ACTIVATED. THE PT WAS BURNED IN GROIN AREA FROM PENCIL OR CLAMP CONTACT. INJURY WAS SIZE OF QUARTER, REQUIRED DEBRIDEMENT AND SUTURES. HOSPITAL RECORDS SHOW PT WAS "OK" WHEN DISCHARGED. IT WAS UNK IF A FOOT-SWITCH WAS ALSO ATTACHED TO THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTONSWITCH PENCIL ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other FORCEFXC ELECTROSURGICAL GENERATOR