BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUCTION COAGULATOR, 10 FR, FOOT CONTROL

    MDR report key: 2809476 · Received October 19, 2012

    Report

    Report Number
    1720159-2012-00103
    Event Type
    Other
    Date Received
    October 19, 2012
    Date of Event
    September 22, 2012
    Report Date
    October 19, 2012
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K052104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED IS RETURNING THE ORIGINAL DEVICE. THE DEVICE IS PRESENTLY IN TRANSIT BETWEEN THE END-USER FACILITY, CONMED LINVATEC (B)(4), AND CONMED CORPORATION (B)(4). UPON COMPLETION OF A QUALITY ENGINEERING INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CONMED THAT, "FIRE STARTED IN OPERATING ROOM. UNCLEAR AS TO WHAT FAILED. ELECTROSURGICAL GENERATOR BEING UTILIZED WAS A ERBBE WHICH HAS BEEN CHECKED AND IS OK." IT WAS NOT LEARNED UNTIL (B)(6) 2012, THAT THER WAS A PT INJURY ASSOCIATED WITH THE EVENT. BURNS RESULTED TO THE MOUTH OF THE PT. FIRE HAD BEEN PUT OUT WITH SALINE. WHEN THE END-USER FACILITY WAS ASKED THE EXTEND OF THE PT INJURIES, TREATMENT IF ANY GIVEN TO THE BURNS, AND OUTCOME OF THE PT; THEY REPLIED THAT THEY DO NOT FEEL THIS PT INFO IS RELEVANT TO INVESTIGATING THE DEVICE EVEN THOUGH I MENTIONED TO THE END-USER FACILITY THAT I MUST REPORT THIS TO THE (B)(4) AND THE FDA IN THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION COAGULATOR, 10 FR, FOOT CONTROL SUCTION COAGULATOR, FDA PRODUCT CODE GEI GEI CONMED CORPORATION NA 12CHL003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Unknown Other ELECTROSURGICAL UNIT - ERBBE BRAND| ELECTROSURGICAL UNIT - ERBBE BRAND