CAUTERY EQUIPMENT BC-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for CAUTERY EQUIPMENT BC-200 manufactured by Circon-acmi.

Event Text Entries

[3595] On 5/11/93 patient had colonoscopy performed in gi lab. A colon polyp was removed by hot biopsy forcep. Patient was discharged in good condition. Later that day the patient experienced abdominal pain and went to the emergency department where perforation of colon was diagnosed. At patient's request, he was transferred to another hospital where surgery for colon perforation was performed. The physician who performed initial colonoscopy felt cautery equiment wasn't operating correctly; i. E. , continues to fire charges after pedal is released. Equipment was removed and examined by clincal engineering department. No problems identified or duplication of md alleged "misfires" could be made. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, performance tests performed. Results of evaluation: none or unknown, inherent risk of procedure, foot switch, power supply. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6802
• MDR Report Key: 6802
• Date Received: 1993-07-22
• Date of Report: 1993-05-17
• Date of Event: 1993-05-11
• Date Facility Aware: 1993-05-11
• Report Date: 1993-05-17
• Date Reported to Mfgr: 1993-05-17
• Date Added to Maude: 1993-10-15
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• 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: CAUTERY EQUIPMENT
• Generic Name: ELECTRO SURGICAL UNIT
• Product Code: FAR
• Date Received: 1993-07-22
• Model Number: BC-200
• ID Number: 4106-CONTROL#
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6485
• Manufacturer: CIRCON-ACMI

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-07-22