BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTWAVE SUCTION ABLATOR

    MDR report key: 2760972 · Received September 26, 2012

    Report

    Report Number
    1017294-2012-00043
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 18, 2012
    Manufacturer
    CONMED LINVATEC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN RECEIVED, THE SERVICE TECHNICIAN EVALUATED/TESTED THE DEVICE, AND FOUND THE ABLATOR TO BE IN GREAT PHYSICAL CONDITION WITH NO EVIDENT DAMAGE TO THE INSULATION, OR TIP OBSERVED. THE ABLATOR WAS FUNCTIONALLY TESTED USING A KNOWN (GOOD) TEST GENERATOR AND PERFORMED AS INTENDED; NO FAULT WAS FOUND. A TWO YEAR REVIEW OF COMPLAINT HISTORY SHOWED NO OTHER REPORTED INJURIES RELATED TO THIS PRODUCT. THERE IS ONE OTHER COMPLAINT FOR THIS ITEM AND LOT NUMBER COMBINATION, AND IS UNRELATED TO A PATIENT BURN. THE RISK DOCUMENT ADDRESSES EXCESSIVE HEAT GENERATION AS AN ACCEPTABLE RISK. RISK ANALYZES SHOWS THAT THE RISK LEVEL CONTINUES TO BE ACCEPTABLE. THE PRODUCT INSTRUCTIONS FOR USE (IFU) HAS SEVERAL WARNINGS RELATED TO PATIENT INJURY. FOR EXAMPLE, THE IFU WARNS: USE CARE WHEN INSERTING INTO AND WITHDRAWING THE ELECTRODE FROM A CANNULA TO AVOID THE POSSIBILITY OF DAMAGE TO THE DEVICES AND/OR INJURY TO THE PATIENT. DO NOT INSERT, WITHDRAW OR TOUCH THE ACTIVE TIP OF THE ELECTRODE WHEN POWER IS BEING APPLIED. THIS MAY RESULT IN AN UNINTENDED SURGICAL EFFECT, INJURY, OR DEVICE DAMAGE. DO NOT USE THE ABLATOR WITH A METAL CANNULA. NON-CONDUCTIVE CANNULAS ARE RECOMMENDED. DO NOT ACTIVATE THE ELECTRODE WHILE ANY PORTION OF THE ELECTRODE TIP IS IN CONTACT WITH ANOTHER METAL OBJECT; LOCALIZED HEATING OF THE ELECTRODE AND THE ADJACENT METAL OBJECT MAY RESULT IN PRODUCT DAMAGE, OR PATIENT AND/OR PERSONNEL INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY: "THE ABLATOR APPEARED TO HAVE BURNED THE PATIENT'S SKIN AROUND THE AREA OF THE WORKING PORTAL. THE SHAFT OF THE LIGHTWAVE WAS DIRECTLY TOUCHING THE AREA OF THE SKIN INVOLVED. THE BURN WAS ASSESSED TO BE OF 1ST TO 2ND DEGREE, AND APPROXIMATELY 2CM IN DIAMETER. THE AREA WAS DRESSED WITH A STERILE DRESSING UNTIL ESCHAR COVERED THE AREA. THE PATIENT WAS SEEN ON 3 WEEKS SINCE THE INJURY, AND THE INCISIONAL AREA HAS BEEN SLOW TO HEAL, IT STILL HAS A SCAB, BUT THE BURN AREA HAS EPITHELIZED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTWAVE SUCTION ABLATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED LINVATEC 1110311

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other