The pencil was reviewed as received by conmed electrosurgery and there was one pencil with two different electrodes, the disposable one sent with the device and a replacement extended electrode.
Only the two electrodes showed any evidence of damage, the pencil was contaminated but was not damaged and worked ok.
The follow up information indicated that when the 130307 was placed in use, the electrode disintegrated "caught fire" when used with a competitive brand (erbe) esu.
Reviewing the electrodes the examination showed the stainless material had "melted" indicating the tip had gotten extremely hot due to the energy transfer to the patient.
In lab practice this has occurred only when using the esu at high power settings (>60w) and arcing small distances for several seconds.
Using beefsteak as the medium, this is also more likely to occur when applying rf to a "fatty pocket" which can flame up.
A more in depth analysis would need to be conducted with various esu's and settings and electrodes to quantify this phenomenon.
The co's experience to date on the various common competitive electrodes is that a majority of the electrodes are stainless steel with perhaps some "grade" difference but with minimal difference in usage.
Competitive esu's will vary somewhat in how they control the rf but again, when the various electrodes are used on the same esu very little difference in usage would be likely.
The pencil electrodes could not be eliminated as a contributor to this event, although usage would also contribute.
No field corrective action is warranted since no device failure was likely and a use error was the major contributor.
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The dir.
Of clinical engineering said when using their newly purchased erbe esu with the co 130307 conmed pencil, when keying it, it burst into flames.
They tried another pencil and it did the same.
This happened about 3/2002.
Then about twenty six days later they tried another conmed pencil, 130307, with the erbe esu and the pencil flamed again.
Refer to mfr report numbers: 1720159-2002-00026, 00027 and 00028.
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