BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2190186 · Received August 4, 2011

    Report

    Report Number
    3005075853-2011-03184
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 18, 2011
    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). THE DEVICE WAS RECEIVED IN THE UNLOCKED POSITION, WITH DRIED TISSUE/BODY FLUIDS IN THE JAWS AND WITH THE CORD CUT OFF.DUE TO THE RETURNED CONDITION, FUNCTIONAL TESTING COULD NOT BE PERFORMED BUT THE DEVICE WAS MECHANICALLY TESTED AND THE JAWS OPENED AND CLOSED WITHOUT DIFFICULTY.THE INSTRUMENT WAS DISASSEMBLED AND NO EVIDENCE WAS FOUND AS TO WHAT COULD HAVE CONTRIBUTED TO THE ACTIVATION ISSUES.IT IS POSSIBLE THAT WHEN THE TISSUE/BODY FLUIDS DRIED, THE JAWS MAY HAVE BECOME DIFFICULT TO OPEN AND CLOSE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN THE INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY, THE JAWS OF THE DEVICE WOULD NOT OPEN TO GRAB THE TISSUE . THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR