BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUAMANTYS 2.3 BIPOLAR SEALER

    MDR report key: 1080673 · Received July 22, 2008

    Report

    Report Number
    1226420-2008-00002
    Event Type
    Other
    Date Received
    July 22, 2008
    Date of Event
    May 23, 2007
    Report Date
    July 16, 2008
    Manufacturer
    SALIENT SURGICAL TECHNOLOGIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K052859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REPORTED BY THE USER COULD NOT HAVE CAUSED THE REPORTED INJURY (RETURN PAD BURN): THE AQM 2.3 DOES NOT UTILIZE A RETURN PAD; IT IS A BIPOLAR DEVICE. THE AQM GENERATOR (THE ONLY GENERATOR THE AQM 2.3 DISPOSABLE IS USED WITH PER LABELING / IFU) DOES NOT PERMIT THE CONNECTION OF A RETURN PAD TO THE GENERATOR. IN THE EVENT THE USER CONNECTED THE AQM 2.3 TO A DIFFERENT GENERATOR IN AN OFF-LABEL USAGE, THE RETURN PAD ASPECT WOULD HAVE NO IMPACT SINCE IT WOULD BE PART OF THE COMPETITOR'S MONOPOLAR OUTPUT CIRCUIT AND IS ELECTRICALLY ISOLATED FROM THE BIPOLAR CIRCUIT (MONOPOLAR CONNECTORS DIFFER FROM BIPOLAR CONNECTORS). ADDITIONALLY, IF THE AQM 2.3 DISPOSABLE WAS CONNECTED TO AN OFF-LABEL GENERATOR, THIS WOULD RESULT IN POOR CLINICAL PERFORMANCE INSUFFICIENT POWER AND CLOGGED TIPS (NO SALINE), AND NOT A RETURN PAD BURN. ADMINISTRATIVE REVIEW: REVIEW OF SALIENT'S COMPLAINT SYSTEM CONFIRMED THERE WAS NO PRIOR REPORT OF THIS INCIDENT TO SALIENT. MEDWATCH WAS RECEIVED ON 23-JUNE-2008. THE MEDWATCH FORM LISTS THE DATE OF THE EVENT AS 2007, AND THE DATE OF THE MEDWATCH REPORT AS 13-JUNE-2008. THE PRODUCT EXPIRATION DATE LISTED ON THE MEDWATCH FORM IS 01-JAN-2007. THIS DATE INDICATES THE PRODUCT WOULD HAVE BEEN EXPIRED AT THE TIME OF ITS USE ON 23-MAY-2007. ADDITIONALLY, THIS EXPIRATION DATE DOES NOT CORRESPOND TO ANY LOT OF SALIENT PRODUCT, REGARDLESS OF CATALOG NUMBER. NO PRODUCT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    RECEIVED ON MONDAY, 23-JUNE-2008: MEDWATCH FORM FROM FDA, POST-MARKED JUNE 20, 2008. CONTENT: DATE OF EVENT: 2007, DATE OF REPORT = 6/13/2008. DESCRIPTION: "EVENT DESC: PEDIATRIC PT TAKEN TO SURGERY FOR LIVER MASS. A BIPOLAR ELECTROSURGICAL DEVICE WAS USED DURING THE PROCEDURE. A GROUNDING PAD WAS PLACED ON THE LEFT SHOULDER. AFTER THE PROCEDURE, IT WAS DISCOVERED THAT THE PT SUSTAINED TWO BURNS TO THE LEFT SHOULDER AREA. THE FIRST BURN WAS A 1.5CM X 1CM FULL THICKNESS BURN AND LOCATED ON THE SUPERIOR ASPECT OF THE LEFT SHOULDER, SLIGHTLY POSTERIOR. THE SECOND BURN WAS ALSO FULL THICKNESS AND MEASURED 2CM X 3CM AND WAS LOCATED ON THE UPPER BACK JUST LATERAL AND INFERIOR TO THE SPINE OF THE SCAPULA. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED (SIC)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUAMANTYS 2.3 BIPOLAR SEALER NONE GEI SALIENT SURGICAL TECHNOLOGIES, INC. 23-113-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other COVIDIEN (VALLEYLAB) GROUNDING PAD, MODEL # E7512