BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2214060 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03347
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072493
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE COMPLAINT WAS FOR AN (B)(4) BUT RECEIVED WAS AN (B)(4). THE DEVICE WAS TESTED WITH A GENERATOR AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED AND THE CUTTING OF THE TEST MEDIA PERFORMED AS EXPECTED. NO ISSUES WERE FOUND WITH THE HANDLE. THE INSTRUMENT WOULD OPEN AND CLOSE AS EXPECTED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. IT IS POSSIBLE THAT THE DEVICE RETURNED WAS THE DEVICE USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON RESECTION THE DEVICE WOULD NOT OPEN WHEN THE HANDLE WAS ACTUATED. THE DEVICE WAS NOT ON A VESSEL OR ARTERY WHEN THE JAWS WOULD NOT OPEN. THERE WAS NO TISSUE TRAUMA REPORTED. 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 H4437G

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR