BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROSURGICAL GENERATOR

    MDR report key: 1233983 · Received November 14, 2008

    Report

    Report Number
    1717344-2008-00527
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 4, 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 RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR, IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SIGNIFICANTLY SEVERE BURN OCCURRED TO A PT DURING A PROCEDURE SOMETIME IN MID-OCTOBER. THE BURN IS BELIEVED TO HAVE OCCURRED AT THE PAD SITE, BUT WAS NOT NOTICED UNTIL SOMETIME LATER. ONCE THE BURN WAS NOTICED, THE GENERATOR WAS REMOVED FROM USE. THE UNIT WAS TESTED BY THE HOSP BIOMEDICAL ENGINEERING DEPT AND FOUND TO FUNCTION PROPERLY. HOWEVER, THE CUSTOMER WANTS TO RETURN IT TO COVIDIEN FOR MORE COMPLETE TESTING. BECAUSE THE BURN WAS NOT NOTICED AT THE TIME OF SURGERY, ALL ACCESSORIES WERE DISCARDED. THE CUSTOMER IS UNABLE TO PROVIDE ANY DETAILS ABOUT ACCESSORY(S) OR PAD. THE SITE REPORTED THAT THE TYPE OF TREATMENT, PROCEDURE, EXACT DATE OF SURGERY, AND PT INFO ARE NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSURGICAL GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other