BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3020555 · Received March 26, 2013

    Report

    Report Number
    3005075853-2013-01397
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 11, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDED ADDITIONAL INFORMATION THE DEVICE WAS RECEIVED WITH THE UPPER JAW BENT, CAUSING SIGNIFICANT REDUCTION TO THE GAP BETWEEN THE ELECTRODE. THE PTC WAS DAMAGED AT THE DISTAL END. DURING FUNCTIONAL TESTING WITH THE GENERATOR, SPARKS WERE NOTED RESULTING IN A YELLOW MESSAGE SCREEN "REPOSITION JAWS AND REACTIVE" WARNING WAS RECEIVED WHEN THE JAWS WERE CLOSED. THEN, THE "REPLACE INSTRUMENT" SCREEN WOULD BE DISPLAYED AFTER RECEIVING THE "REPOSITION AND REACTIVATE" MESSAGE TWICE. THE UPPER JAW WAS VISUALLY INSPECTED, AN IMPRINT OF THE ELECTRODE WAS FOUND ON THE PTC. WHEN THE JAWS WERE CLOSED, THE GAP REDUCTION ALLOWED ARCING TO DEVELOP RESULTING IN SPARKING AND IN PTC MATERIAL FURTHER DETERIORATION; BLACK RESIDUES ON THE ELECTRODE ARE CAUSED BY THIS PTC DETERIORATION. THE DAMAGE FLATTENED THE PTC WHICH RESULTED IN THE UPPER JAW TO BE IN CONTACT WITH THE ELECTRODE CREATING AN ELECTRICAL SHORT AND A YELLOW SCREEN ALERT, PREVENTING DEVICE WORKS WITH THE GENERATOR.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE SPARKED INSIDE THE ABDOMEN. THEY PULLED THE DEVICE OUT OF THE PATIENT AND IT STARTED A LITTLE FIRE AT THE TIP OF THE DEVICE. NO INJURY TO THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123427 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4C84R

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR