BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONO STAN RF FORCEPS

    MDR report key: 1581205 · Received January 14, 2010

    Report

    Report Number
    2428235-2010-00001
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 11, 2009
    Report Date
    December 15, 2009
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K71343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IEC-MJ11 STAN FORCEP WAS RETURNED. WE HAVE REQUESTED THAT ANY PHOTOS OF THE INJURY BE PROVIDED, BUT NONE HAVE BEEN MADE AVAILABLE. WE TESTED BOTH THE RETURNED FORCEP AND SAMPLES FROM OUR INVENTORY AT A WIDE RANGE OF POWER SETTINGS INCLUDING FULL POWER SETTING OF 100 AND FOUND THAT THERE WAS NOT SUFFICIENT HEAT GENERATED THROUGH THE INSULATION TO BURN TISSUE EVEN WITH EXTENDED CONTACT. OUR TECHNICIANS HELD THE FORCEPS WHILE ACTIVATED AND CUTTING WITHIN A VERY SHORT DISTANCE FROM THE ACTIVATED TIP WITHOUT ANY RISE IN TEMPERATURE THROUGH THE INSULATION. WE THEN PLACED THE ACTIVATED FORCEP TIP (RATHER THAN THE INSULATED SHAFT) IN DIRECT CONTACT WITH A RETRACTOR WITH THE RETRACTOR IN CONTACT WITH TISSUE. THE RETRACTOR DID BURN THE TISSUE IT CONTACTED WHEN THE FORCEP WAS ACTIVATED TO A SETTING OF 100, IN UNDER 20 SECONDS. THE AMOUNT OF TIME IT TAKES TO CAUSE A BURN WILL BE DIRECTLY RELATED TO THE AMOUNT OF RETRACTOR SURFACE AREA IN CONTACT WITH TISSUE, THE ACTIVATION TIME WHILE IN CONTACT WITH AN ACTIVATED ELECTRODE TIP, AND THE POWER. ELLMAN'S INSTRUCTIONS FOR USE SPECIFY THAT THE POWER BE SET TO THE LOWEST LEVEL NEEDED TO EFFECTIVELY OPERATE. THE POWER SETTINGS USED DURING BREAST IMPLANT SURGERY WITH THE MJ11 STAN FORCEP WILL BE AROUND 25-30 IN CUT MODE AND 35-45 IN HEMO MODE. THIS IS CONSIDERABLY LOWER THAN WHAT WAS DESCRIBED. ELLMAN'S INSTRUCTIONS FOR USE ALSO CAUTION THAT THE PATIENT SHOULD NOT COME INTO CONTACT WITH METAL. USING A METAL RETRACTOR WITHOUT INSULATING IT FROM THE ACTIVATED ELECTRODE TIP WOULD CERTAINLY LEAD TO A BURN. ADDITIONALLY, ELLMAN'S INSTRUCTIONS FOR USE DETAIL THAT DIRECT CONTACT BETWEEN THE ACTIVE ELECTRODE TIP AND METAL WILL TRANSMIT ENERGY TO THE PATIENT AND CAN IN FACT BE USED FOR "INDIRECT" COAGULATION. IF FOR ANY REASON, THE FORCEP WAS GETTING HOT ENOUGH DURING THE TREATMENT TO LEAD TO A BURN THROUGH THE INSULATION, THEN THE SURGEON WOULD ALSO FEEL THE HEAT WHILE HOLDING THE HANDPIECE AND WE WOULD HAVE BEEN ABLE TO DUPLICATE THIS IN OUR LABORATORY. TO LEAD TO A TISSUE BURN, EITHER THE ACTIVE ELECTRODE WOULD HAVE BEEN IN DIRECT CONTACT WITH THE TISSUE OR IN INDIRECT CONTACT WITH THE TISSUE THROUGH THE RETRACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MANUFACTURER'S DISTRIBUTOR THAT DURING A BREAST PROCEDURE AT A LOCAL HOSPITAL THAT INVOLVED BOTH BREASTS, THE PATIENT RECEIVED A THIRD-DEGREE BURN ON THE AREOLA OF ONE BREAST. THE IEC-MJ11 MONO STAN RF FORCEPS WERE USED WITH THE SURGITRON DUAL RF GENERATOR. THE GENERATOR SETTINGS WERE AT 90 CUT/COAG, 100 HEMO. THE TOTAL PROCEDURE LASTED ONE HOUR. DURING THE FIRST 30 MINUTES, THERE WAS NO ILL EFFECT. AFTER A TEN MINUTE BREAK, THE PROCEDURE RESUMED ON THE OTHER BREAST LASTING 30 MINUTES. A RETRACTOR WAS USED BETWEEN THE FORCEPS AND THE BREAST. THE PHYSICIAN DID NOT FEEL THE FORCEPS GETTING ABNORMALLY HOT. THE INJURED TISSUE WAS REMOVED DURING THE SURGERY AND THE PATIENT HAD NO ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONO STAN RF FORCEPS GEI ELLMAN INT'L INC. IEC-MJ11

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention