BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR (SHANGHAI)

    MDR report key: 2961040 · Received January 16, 2013

    Report

    Report Number
    1717344-2012-01275
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 21, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GENERATOR HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE UNIT EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HALF WAY THROUGH A BLEPHAROPLASTY PROCEDURE THERE WAS A FLASH WHEN USING THE ELECTROSURGICAL PENCIL. THE EQUIPMENT WAS SET ON 15 CUT AND 15 COAGULATION, AND NO ALARM SOUNDED. WHEN THE FLASH OCCURRED, THE PATIENT'S LEFT EYE WAS BEING WORKED ON, AND THE PATIENT'S LEFT EYELID AND EYELASHES WERE BURNED. THE BURNS WERE DESCRIBED AS FIRST DEGREE AND WERE TREATED WITH A SALINE SOLUTION AND TOPICAL CREAM. THE SURGERY WAS EXTENDED MORE THAN 30 MINUTES DUE TO THIS INCIDENT. THE SURGEON SPECULATES THE FLASH MAY HAVE BEEN CAUSED BY OXYGEN ACCUMULATION FROM NASAL GLASSES THE PATIENT WAS WEARING. THE PATIENT HAS BEEN RELEASED FROM THE HOSPITAL WITH FURTHER MEDICAL FOLLOW-UP PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23875 FORCE FX-8C GENERATOR (SHANGHAI) ELECTROSURGICAL GENERATOR GEI COVIDIEN LLC (SHANGHAI)

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR UNKNOWN ELECTROSURGICAL PENCIL, LOT# UNKNOWN