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Adverse Event Report

CONMED CORP. ELECTROSURGICAL UNIT   back to search results
Model Number MF380
Event Date 07/18/1995
Patient Outcome  Other;
Event Description

Pt id: 420002-1995-0004. During operative procedure, right femoral posterior tibial by-pass, noted 3 cautery tip "burns" by surgeon to right inner thigh just above knee. One cautery hand control being used by surgeon activated the other hand control cautery lying on pt's leg. Cautery holder in place on sterile field. 2 cautery hand controls used with 1 cautery machine setting on 30 coag with 1 cautery grounding pad in place preoperatively to left upper thigh. Cautery machine #2 received from er. One hand control switched to this cautery with a new bovie pad placed on pt's upper chest. Cauter #2 setting on 30 coag. A total of 2 cautery machines, 2 cautery grounding pads, 2 cautery hand controls now used. Both grounding pads attached properly to pt & cautery.

 
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Brand NameELECTROSURGICAL UNIT
Type of DeviceELECTROSURGICAL UNIT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CONMED CORP.
310 broad st.
utica NY 13501 1203
Manufacturer (Section D)
CONMED CORP.
310 broad st.
utica NY 13501 1203
Device Event Key27409
MDR Report Key26649
Event Key24853
Report Number26649
Device Sequence Number1
Product CodeGEI
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/19/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/08/1995
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberMF380
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/18/1995
Device Age12 yr
Event Location Hospital
Date Report TO Manufacturer07/20/1995
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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