BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3962615 · Received July 29, 2014

    Report

    Report Number
    3005075853-2014-05292
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 18, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER PROVIDED IS AN INVALID BATCH NUMBER FOR THIS PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAW BECAME NOT TO OPEN AFTER THE I-BLADE WAS MOVED FORWARD COMPLETELY. NO ERROR CODE WAS DISPLAYED. THE JAW WAS OPENED BY RETURNING THE HANDLE TO THE HOME POSITION BY HAND. THERE WAS NO DAMAGE TO THE TARGET TISSUE. . ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440773 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR