BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSEAL

    MDR report key: 2931301 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00328
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYN PROCEDURE, A PIECE OF THE ENSEAL BROKE OFF THE JAW AND POSSIBLY FELL INTO THE PATIENT. AFTER SPEAKING TO CUSTOMER, THEY WERE ABLE TO FIND A PIECE OF THE ELECTRODE AND A PIECE OF THE I-BLADE, BUT WERE STILL GOING TO X-RAY TO SEE IF THEY COULD FIND ANY MORE PIECES INSIDE THE PATIENT. NO ADDITIONAL DETAILS WERE KNOWN. ADDITIONAL INFORMATION REQUESTED ON RESULTS OF X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37491 NSEAL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR