BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 2955530 · Received February 11, 2013

    Report

    Report Number
    3005075853-2013-00544
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 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
    KS
    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). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. HOWEVER THE ELECTRODE WAS FOUND PROPERLY ATTACHED TO THE DEVICE AND NOT BROKEN AS REPORTED BY THE CUSTOMER. DURING FUNCTIONAL TESTING WITH THE GENERATOR, SPARKS WERE NOTED AND A REPLACE DEVICE WARNING WAS RECEIVED WHEN THE JAWS WERE CLOSED. 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 REPLACE LIGHT ILLUMINATED, PREVENTING RF POWER DELIVERY FROM THE GENERATOR. PLEASE NOTE THAT THESE FINDINGS ARE UNRELATED WITH THE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED TOTAL HYSTERECTOMY THE ELECTRODE WAS LIFTED. NO PATIENT CONSEQUENCES. ONE DEVICE WILL BE RETURNING. PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. PROCEDURE WAS PROLONGED BY 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58857 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR