BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 1971451 · Received January 14, 2011

    Report

    Report Number
    1717344-2010-01011
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 27, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO 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 LAPAROSCOPIC COLECTOMY, A MEGADYNE HANDPIECE IN USE WITH THE GENERATOR, SELF ACTIVATED AND SPARKED WHEN IT WAS PLACED NEAR GAUZE THAT WAS SOAKED WITH SALINE SOLUTION. THE SPARK INJURED THE PT'S BOWEL AND SLIGHT SYMPTOMS OF ILEUS WERE NOTED. AN UNK FOOT SWITCH WAS CONNECTED TO THE GENERATOR, BUT WAS NOT IN USE AT TIME OF THE INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other UNK FOOT SWITCH - LOT NUMBER UNK| MEGADYNE HANDPIECE - LOT NUMBER UNK