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Adverse Event Report

CONMED ELECTROSURGERY CONMED ELECTROSURGICAL PENCIL   back to search results
Model Number CONMED PENCIL
Event Date 03/31/2002
Event Type  Malfunction  
Manufacturer Narrative

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.

 
Event Description

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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Brand NameCONMED
Type of DeviceELECTROSURGICAL PENCIL
Baseline Brand NameCONMED
Baseline Generic NameELECTROSURGICAL PENCIL
Baseline Catalogue Number131307
Baseline Model NumberCONMED PENCIL
Baseline Device FamilyDISPOSABLE CONMED PENCIL, STERILE
Baseline Device 510(K) NumberK791137
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed07/24/1979
Manufacturer (Section F)
CONMED ELECTROSURGERY
14603 east fremont avenue
centennial CO 80112
Manufacturer (Section D)
CONMED ELECTROSURGERY
14603 east fremont avenue
centennial CO 80112
Manufacturer Contact
genny stommel, specialist
14603 east fremont ave
centennial , CO 80112
(303) 699 -7600 ext 5225
Device Event Key381907
MDR Report Key392876
Event Key371143
Report Number1720159-2002-00028
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/05/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/01/2006
Device MODEL NumberCONMED PENCIL
Device Catalogue Number130307
Device LOT Number010802-1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/15/2002
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/05/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/03/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ERBE ESU,

Database last updated on January 30, 2009

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