BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 4102908 · Received September 19, 2014

    Report

    Report Number
    3005075853-2014-06535
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 5, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED WITH THE JAWS MISALIGNED. UPON INSPECTION UNDER MAGNIFICATION OF THE JAW IT WAS NOTED THAT ONE OF THE RETENTION PINS THAT HOLD THE JAWS IN POSITION WAS BENT. HOWEVER THE DEVICE COULD BE TESTED FOR FUNCTIONALITY. THE DEVICES WAS TESTED ON THE GENERATOR AND PASSED ALL FUNCTIONAL TESTING. THE ENERGY OUTPUT DELIVERED FROM THE DEVICE WAS VERIFIED. ALL THREE TONES WERE HEARD DURING FUNCTIONAL TESTING (TONE 1 IS HEARD WHEN THE ENERGY ACTIVATION BUTTON IS PRESSED; TONE 2 IS HEARD WHEN TISSUE IMPEDANCE THRESHOLD IS REACHED; AND TONE 3 IS HEARD WHEN THE CYCLE IS COMPLETE). THERE WERE NO ANOMALIES NOTED WITH THE PTC AND WITH THE ELECTRODE AND CERAMIC OF THE DEVICE. THERE WERE NO ALERT SCREENS DISPLAYED AT ANY TIME DURING THE FUNCTIONAL TEST. A PROBABLE CAUSE OF THE DAMAGE TO THE RETENTION PINS COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL LAPAROSCOPIC COLECTOMY PROCEDURE, WAS TOLD BY THE SURGEON THAT THE JAWS OF THE DEVICE WERE NOT FULLY OPENING. HE ALSO NOTICED THAT THE ELECTRODE LOOKED LIKE IT WAS COMING LOOSE OR WAS NOT SEATED CORRECTLY. THEY RECEIVED A FEW ERRORS AND AFTER TRYING TO FIX IT A FEW TIMES THEY OPENED A NEW DEVICE. WHEN CLOSING THE JAWS, OUTSIDE OF THE PATIENT, THE JAWS NOT WOULD OPEN. CASE COMPLETED WITH ANOTHER DEVICE OF A DIFFERENT PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584144 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR