BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAMANTYS 6.0 BIPOLAR SEALER

    MDR report key: 1414875 · Received June 26, 2009

    Report

    Report Number
    1226420-2009-00001
    Event Type
    Other
    Date Received
    June 26, 2009
    Date of Event
    May 22, 2009
    Report Date
    June 26, 2009
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MEDWATCH FORM DESCRIBED A PRODUCT PROBLEM INVOLVING THE SALIENT SURGICAL AQUAMANTYS 6.0 BIPOLAR SEALER DEVICE AS FOLLOWS, "NO CURRENT TO DEVICE TO CREATE DESIRED EFFECT, AFTER INSTRUMENT WENT THROUGH TROUBLESHOOTING SECOND DEVICE OPENED AND FUNCTIONED PROPERLY WITHOUT FURTHER DIFFICULTY." THIS INFO WAS ALSO DESCRIBED IN THE SAME WAY TO A SALIENT SURGICAL SALES REP BY MS. (B)(4). THERE WAS NO INDICATION ON THE MEDWATCH FORM OR IN MS. (B)(4)'S INITIAL CONVERSATION WITH SALIENT'S SALES REP OF A PT INJURY OR ADVERSE EVENT ARISING FROM THIS INCIDENT. THIS INFO WAS CONFIRMED ONCE AGAIN BY MS. (B)(4) IN A F/U CONVERSATION BETWEEN SHE AND THE SALIENT SALES REP. MS. (B)(4) DID CONFIRM WITH SALIENT'S SALES REP THAT THE HOSPITAL HAS THE DEVICE IN QUESTION. ATTEMPTS HAVE BEEN MADE ON 3 OCCASIONS EITHER BY PHONE OR IN PERSON BY SALIENT'S REGULATORY MGR AND SALES REP TO OBTAIN ADD'L INFO AND THE DEVICE FOR INVESTIGATIVE PURPOSES, HOWEVER, AS OF TODAY, (B)(4) 2009, NO ADD'L INFO HAS BEEN PROVIDED NOR HAS ANY DEVICE BEEN RETURNED TO SALIENT SURGICAL. A LOT HISTORY REVIEW WAS DONE. LOT RELEASED. NO PERTINENT FINDINGS.

    Description of Event or Problem · 1

    A MEDWATCH FORM WAS RECEIVED BY SALIENT SURGICAL ON (B)(6) 2009, STATING THE FOLLOWING, " NO CURRENT TO DEVICE TO CREATE DESIRED EFFECT, AFTER INSTRUMENT WENT THROUGH TROUBLESHOOTING SECOND DEVICE OPENED AND FUNCTIONED PROPERLY WITHOUT FURTHER DIFFICULTY. MFR RESPONSES FOR 6.0 BIPOLAR SEALER, AQUAMANTYS. OR MATERIALS COORD HAS CALLED AND SPOKEN TO REP. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? TIBIAL SPACER REMOVAL, PLACEMENT OF POSTERIOR ILIAC CREST BONE GRAFT TO TIBIA. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING."

    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 TLH22800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK