WOLF BOVIE CORD NOT AVAILABLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-11-10 for WOLF BOVIE CORD NOT AVAILABLE * manufactured by Richard Wolf Medical Instruments Corp..

Event Text Entries

[135993] Surgeon implied bovie was not working. Checked connection. Cord began to smoke, then sparked and flames appeared. Fire was extinguished rapidly and cord was removed from room.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017539
• MDR Report Key: 249455
• Date Received: 1999-11-10
• Date of Report: 1999-11-09
• Date of Event: 1999-10-29
• Date Added to Maude: 1999-11-15
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WOLF BOVIE CORD
• Generic Name: BOVIE CORD
• Product Code: MOD
• Date Received: 1999-11-10
• Model Number: NOT AVAILABLE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 241677
• Manufacturer: RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• Manufacturer Address: 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US
• Baseline Device Family: RESPIRATORY KIT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-11-10