BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 7767895 · Received August 9, 2018

    Report

    Report Number
    1717344-2018-01054
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 24, 2018
    Report Date
    October 2, 2018
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884524000985
    PMA / PMN Number
    K822572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AFTER AN ATRIAL FIBRILLATION ABLATION, A PATIENT FOUND TO HAVE GROUNDING PAD SITE BURN. IT WAS NOTED THAT THE INTEGRATED PRECISION LAB DID NOT USE A FLUOROSCOPY. ALSO NOTED THAT THE CUSTOMER WAS USING A FLEXIBILITY CATHETER, 3.5 MM IRRIGATED TIP. THE RETURNED PATCH WAS PLACED 1 INCH RIGHT OF THE SPINE AT THE APEX OF SCAPULA.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AFTER AN ATRIAL FIBRILLATION ABLATION, A PATIENT HAD FOUND TO HAVE GROUNDING PAD SITE SECOND DEGREE BURN. TOPICAL OINTMENT WAS APPLIED ON THE BURN SITE. THE RETURN PATCH WAS PLACED 1 INCH RIGHT OF THE SPINE AT THE APEX OF SCAPULA. IT WAS NOTED THAT THE INTEGRATED PRECISION LAB DID NOT USE A FLUOROSCOPY. ALSO NOTED THAT THE CUSTOMER WAS USING A FLEXIBILITY CATHETER, 3.5 MM IRRIGATED TIP WITH INTRACARDIAC ECHOCARDIOGRAPHY THE ENTIRE PROCEDURE. GENERATOR SETTING OF 30-50 W. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607343 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER E7506- 10884524000985

    Patients

    Seq Age Sex Outcome Treatment
    1 Other