BRITCHER 6400 ARGON *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-06 for BRITCHER 6400 ARGON * manufactured by Birtcher Medical Systems.

Event Text Entries

[19776108] Flame shot out of cautery and physician experienced several episodes of "shock feeling" throughout his body. Also sustained burn on finger.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 67800
• MDR Report Key: 67800
• Date Received: 1997-01-06
• Date of Report: 1996-08-07
• Date of Event: 1996-08-05
• Date Facility Aware: 1996-08-07
• Report Date: 1996-08-07
• Date Reported to Mfgr: 1996-08-07
• Date Added to Maude: 1997-02-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BRITCHER 6400 ARGON
• Generic Name: BEAM COAGULATOR
• Product Code: LMS
• Date Received: 1997-01-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 67810
• Manufacturer: BIRTCHER MEDICAL SYSTEMS
• Manufacturer Address: 50 TECHNOLOGY DR IRVIN CA 92718 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-01-06