BOVIE CSV N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-02 for BOVIE CSV N/A manufactured by Libel-flarsheim, Division Of Ritter.

Event Text Entries

[20884435] On 2/10/92, 93 year old female undergoing tracheostomy procedure in operating room. Endotracheal tube in place. Bovie being used. Sudden loud noise as smoke emanated from tracheal tube, folowed by bluish-white flame. Surgeon immediately suctioned patient. Aflexible bronchoscopy was done with lavage. 2/13/92 - patient is alert and stable with no evidence of smoke inhalation or alveoli damage. Electrosurgical unit was evaluated and found to be within manufacturer's specifications. No deficiencies were found with the devicedevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-dec-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed, visual examination. Results of evaluation: other, other, other. Conclusion: device evaluated and alleged failure could not be duplicated. 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: 293
• MDR Report Key: 293
• Date Received: 1992-03-02
• Date of Report: 1992-02-13
• Date of Event: 1992-02-10
• Date Facility Aware: 1992-02-10
• Report Date: 1992-02-13
• Date Reported to FDA: 1992-02-13
• Date Added to Maude: 1992-04-15
• 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: BOVIE
• Generic Name: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1992-03-02
• Model Number: CSV
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 288
• Manufacturer: LIBEL-FLARSHEIM, DIVISION OF RITTER

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-03-02