BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARYLAND JAW LAP (37CM)

    MDR report key: 3952065 · Received July 17, 2014

    Report

    Report Number
    1717344-2014-00604
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LF1737 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND TISSUE IN THE JAWS OF THE DEVICE BUT THE DEVICE APPEARED VERY CLEAN FOR A HYSTERECTOMY PROCEDURE. THE CORD OF THE DEVICE WAS CUT. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION MECHANICALLY AND THE WELDS TO BE SATISFACTORY. THE JAW GAP OF THE DEVICE WAS MEASURED AND PASSED. CUT MEDIA TEST WAS PERFORMED AND PASSED. CONTINUITY TEST WAS PERFORMED AND PASSED. SINCE THE CORD OF THE DEVICE WAS CUT, A NEW CORD WAS RE-SPLICED IN ORDER TO PERFORM THE TISSUE TESTING. THE DEVICE WAS PLUGGED INTO A FORCETRIAD AND TESTED ON SIMULATED TISSUE WITH SATISFACTORY RESULTS. THE DEVICE WAS ALSO TESTED ON PORCINE KIDNEY ARTERIES OF VARYING DIAMETER AND FUNCTIONED AS NORMAL. IN ADDITION, THE JAW FORCE OF THE DEVICE WAS TESTED WITH SATISFACTORY RESULTS. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE DEVICE DID NOT SEAL EFFECTIVELY DURING THE PROCEDURE. END TONES, INDICATING A COMPLETE SEAL CYCLE, WERE PROVIDED BY THE GENERATOR IN USE. THE BLEEDING WAS NOTED AFTER THE PROCEDURE AND THE PATIENT NEEDED A RE-OPERATION TO REPAIR THE SEALS. THE PATIENT IS REPORTED AS HAVING RECOVERED FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420306 MARYLAND JAW LAP (37CM) LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other