BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUS THERMAL TISSUE FUSION SYSTEM HANDPIECE 10MM X 23 CM

    MDR report key: 2940872 · Received February 4, 2013

    Report

    Report Number
    1720159-2013-00011
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K101534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALTRUS THERMAL TISSUE FUSION SYSTEM IS INDICATED FOR OPEN AND LAPAROSCOPIC TECHNIQUES IN GENERAL SURGICAL AND GYNECOLOGICAL PROCEDURES FOR LIGATION (SEALING) AND DIVIDING (CUTTING) OF TISSUE WHEN HEMOSTASIS IS DESIRED. THE ORIGINAL ALTRUS HANDPIECE UTILIZED IN THE PROCEDURE WAS RETURNED TO CONMED CORPORATION FOR EVALUATION. THE QUALITY ENGINEERING EVALUATION INCLUDED A VISUAL INSPECTION WHERE NO DEFECTS WERE OBSERVED. THE EVALUATION ALSO INCLUDED FUNCTIONALITY TESTING AND THE RETURNED DEVICE PASSED. THE DEVICE SUCCESSFULLY CUT AND SEALED WHEN ACTIVATED AND PERFORMED AS EXPECTED. THE REPORTED MALFUNCTION COULD NOT BE REPRODUCED AND IS UNCONFIRMED. THE BLEEDING THAT OCCURRED IN THIS INCIDENT WAS THE RESULT OF AN IMPROPER SEAL NOT GENERATING FULL VESSEL LIGATION. THE SOFTWARE PARAMETER VERIFICATION WAS DOWNLOADED FROM THE ACTUAL DEVICE AND THE SEAL ALGORITHM PARAMETERS PASSED, AS WELL AS THE CUT ALGORITHM PARAMETERS. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED ANY MANUFACTURING DEFECTS REGARDING THE SEALING FUNCTION OF THE DEVICE; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME. CONMED CORPORATION IS CONSIDERING THIS COMPLAINT CLOSED.

    Additional Manufacturer Narrative · 1

    THIS IS AN FDA REPORTABLE EVENT DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 1720159-2012-00093 AND 1720159-2012-00096. THIS DEVICE HAS BEEN RETURNED TO CONMED CORPORATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN INITIATED. UPON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "SURGEON ATTEMPTED TO SEAL A BLEEDER AND THE HANDPIECE WOULD NOT SEAL AFTER MULTIPLE ATTEMPTS. DOUBLE SEALED, ATTEMPTED TO SEAL DISTAL TO FIRST SEAL WITH NO LUCK. TRIED SEAL 4-5 TIMES BEFORE GIVING UP. USED LIGASURE IMPACT, SUTURES." IT WAS ALSO REPORTED THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47187 ALTRUS THERMAL TISSUE FUSION SYSTEM HANDPIECE 10MM X 23 CM ALTRUS HANDPIECE GEI CONMED ELECTROSURGERY 12LHB002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention