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Adverse Event Report

CONMED CORPORATION CONMED ELECTROSURGICAL DISPERSIVE ELECTRODE DISPERSIVE ELECTORDE   back to search results
Catalog Number 400-0183
Event Date 07/23/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

The actual device was rec'd and visually examined. There was a large clump of hair concentrated at the burn spot of the ground pad. The ground pad placement was longitudinal and contraindicates co's instructions. The pt was excessively hairy and not prepped according to co's recommendatiions. Hair present may have caused gapping in the ground pad contact. The ground pad used would not have alarmed the machine as it is a single foil pad and not a monitoring pt-to-pad contact. User error caused this event. This distributor has been notified of the error.

 
Event Description

It was reported that a male pt rec'd 1 sq. Cm. Of burning, 2nd degree, during an operation of a tibiofibular on the right leg. The spot turned black and carbonized. A nurse put this ground pad on the left thigh without shaving excessively hairy. At the power of 40w, this pt complained about numbness. When the esu power was raised to 50w, he complained of strong pad at the area of the ground pad. The nurse found the burning, the ground pad was placed properly and nothing wrong was found on the ground pad. This machine has a function/capability of alarm but did not alarm during the operation.

 
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Brand NameCONMED ELECTROSURGICAL DISPERSIVE ELECTRODE
Type of DeviceDISPERSIVE ELECTORDE
Baseline Brand NameDISPERSIVE ELECTRODE
Baseline Generic NameGROUND PAD
Baseline Catalogue Number400-0183
Baseline Device FamilyCONMED DISPERSIVE ELECTRODES
Baseline Device 510(K) NumberK945633
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed01/25/1991
Manufacturer (Section F)
CONMED CORPORATION
310 broad street
utica NY 13501
Manufacturer (Section D)
CONMED CORPORATION
310 broad street
utica NY 13501
Manufacturer (Section G)
CONMED CORP.
310 broad st.
utica NY 13501 1203
Manufacturer Contact
heather decarlo
310 broad st
utica , NY 13501
(315) 797 -8375 ext 2314
Device Event Key112986
MDR Report Key115111
Event Key108271
Report Number1317214-1997-00103
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/28/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number400-0183
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/23/1997
Device Ageunknown
Event Location Hospital
Date Manufacturer Received07/28/1997
Was Device Evaluated By Manufacturer? Yes
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: 08/25/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,ESU,

Database last updated on December 31, 2008

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