BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 1212556 · Received October 27, 2008

    Report

    Report Number
    1226420-2008-00004
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 27, 2008
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED; THEREFORE, NO EVALUATION WAS COMPLETED. NO DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    IN 2008, A SALIENT SURGICAL AQUAMANTYS 6.0 DEVICE WAS USED IN A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE. THE SURGEON IS AN EXPERIENCED USER OF SALIENT TECHNOLOGY AND THIS WAS HIS 28TH CASE USING THE AQM 6.0 DEVICE. THE SALIENT SALES REPRESENTATIVE PRESENT DURING THIS SURGERY REPORTED TO SALIENT CORPORATE THAT THERE WAS COMPLICATION WITH THE SURGERY RESULTING IN A SERIOUS INJURY TO THE PATIENT NOT RELATED TO THE USE OF THE SALIENT DEVICE. THE SALIENT SALES REPRESENTATIVE STATED THAT THE PATIENT STARTED BLEEDING HEAVILY BEHIND THE KNEE FOLLOWING PLACEMENT OF IMPLANTS AND DROPPING OF TOURNIQUET. SHE REPORTED THAT AFTER APPROX. 5 MINUTES AND THE APPLICATION OF A HEMOSTAT, THE BLEEDING SLOWED AND THE INCISION WAS CLOSED. THE SALIENT SALES REPRESENTATIVE THEN LEFT THE OPERATIVE ROOM. WHEN SHE RETURNED APPROXIMATELY 45 MINUTES LATER, SHE LEARNED FROM THE SURGEON THAT THE PATIENT EXPERIENCED FURTHER BLEEDING RESULTING IN LOSS OF PULSE IN HER LOWER LEG AND A HEART RATE OF 30. ACCORDING TO THE SURGEON, THE PATIENT WAS TAKEN FOR A CT SCAN AND A VASCULAR SURGEON WAS BROUGHT IN TO REPAIR A TEAR IN THE POPLITEAL ARTERY. AT NO TIME WAS THIS INJURY ATTRIBUTED TO THE USE OF THE SALIENT SURGICAL TECHNOLOGIES AQUAMANTYS DEVICE. ON TWO DAYS LATER, THE SALIENT SALES REPRESENTATIVE FOLLOWED UP WITH THE SURGEON ABOUT THIS CASE. THE SURGEON REPORTED THAT THE PATIENT IS DOING FINE. HE STATED THAT THE POPLITEAL ARTERY HAD A SLIGHT TEAR IN IT, MOST LIKELY DUE TO RETRACTOR PLACEMENT DURING SURGERY. THERE WERE NO COMPLAINTS ABOUT SALIENT DEVICE BY THE SURGEON OR HOSPITAL FOLLOWING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 6.0 BIPOLAR SEALER AQUAMANTYS 6.0 BIPOLAR SEALER GEI SALIENT SURGICAL TECHNOLOGIES, INC. 23-112-1 TLF15800

    Patients

    Seq Age Sex Outcome Treatment
    1 UKNOWN Required Intervention