BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSEAL

    MDR report key: 3071246 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01907
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE INSTRUCTIONS FOR USE STATE: AVOID USE OF GENERATOR G11 ADJACENT TO OR STACKED WITH OTHER EQUIPMENT. IF ADJACENT OR STACKED USE IS NECESSARY, MONITOR THE GENERATORG11 AND THE OTHER EQUIPMENT TO ASSURE NORMAL OPERATION. INTERFERENCE PRODUCED BY THE OPERATION OF HIGH-FREQUENCY SURGICAL EQUIPMENT MAY ADVERSELY AFFECT THE OPERATION OF OTHER ELECTRONIC MEDICAL EQUIPMENT SUCH AS MONITORS AND IMAGING SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOVIE CAUSED THE ENSEAL DEVICE TO ACTIVATE AUTOMATICALLY DURING A LAPROSCOPIC COLON CASE. THE CASE WAS STILL COMPLETED WITH THE SAME EQUIPMENT. NO PATIENT CONSEQUENCE. DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171617 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR