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Adverse Event Report

CONMED ELECTROSURGERY BIRTCHER ELECTROSURGICAL UNIT   back to search results
Model Number SYSTEM 6000 ABC
Event Date 09/01/2003
Event Type  Other   Patient Outcome  Other;
Event Description

A pt was burned on the leg at the corner of the grounding pad.

 
Manufacturer Narrative

The device was not returned to conmed electrosurgery. Follow up info stated that the unit was tested as ok by the hospital biomed and the esu was returned to use. Given the description that the burn occurred at or near the return pad site this was a possible rf pad placement burn. The esu device was not stated to have had any problems thus it was apparently working properly for output during the procedure. No conclusion was made indicating the absolute cause however the esu was not the likely major contributor to this incident. It should be on the recommended pm schedule to ensure it's proper operation. No field corrective action is warranted since the esu was tested ok and was apparently operating properly at the time of the incident. Ensure the device is on a regular pm.

 
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Brand NameBIRTCHER
Type of DeviceELECTROSURGICAL UNIT
Baseline Brand NameBIRTCHER
Baseline Generic NameELECTROSURGICAL UNIT
Baseline Catalogue Number136060
Baseline Model NumberSYSTEM 6000 ABC
Baseline Device FamilySYSTEM 6000 ABC
Baseline Device 510(K) NumberK871435
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/01/1987
Date Ceased Marketing12/01/1997
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
rebecca bernie
14603 east fremont ave
centennial , CO 80112
(303) 699 -7600 ext 5225
Device Event Key481092
MDR Report Key492388
Event Key466794
Report Number1720159-2003-00103
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 09/29/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberSYSTEM 6000 ABC
Device Catalogue Number136060
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/01/2003
Device Ageunknown
Event Location Hospital
Date Manufacturer Received09/29/2003
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/27/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,GROUNDING PAD - MANUFACTURER UNK.,

Database last updated on January 30, 2009

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