BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3872572 · Received May 22, 2014

    Report

    Report Number
    1717344-2014-00385
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT UNIT WOULD NOT BE RETURNING FOR EVALUATION. HOWEVER, THE SITE PERFORMED AN INTERNAL SAFETY CHECK ON THE UNIT. IT PASS AND WAS RETURNED TO THE OPERATION ROOM. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT RECEIVED A BURN FROM A FORCEP WHICH HAD BEEN DETERMINED AND TRANSFERRED TO THE PATIENT. THE SITE DECLINED TO PROVIDE ADDITIONAL INFORMATION ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306602 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK FORCEP