MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; SUCTION COAGULATOR

Model Number	SCH08
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that during an endoscopic video turbinectomy surgery, the doctor pressed the button to activate the equipment and received a burn on this finger.There was no harm to the patient and no further harm to the user.
Additional Manufacturer Narrative
Product was unable to be returned to symmetry for further evaluation.Therefore complaint could not be confirmed.True root cause is unable to be determined at this time.The manufacturing dhr record for lot# 200606166.It was confirmed that all inspections were completed with nothing found to be out of conformance.This is an isolated event with no further actions required based on the investigation.This can be seen as the final report.If any additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: SUCTION COAGULATOR
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 12450838
• Report Number: 3007208013-2021-00027
• Device Sequence Number: 4264495
• Product Code: GEI
• UDI-Device Identifier: 00607151006525
• UDI-Public: 00607151006525
• Combination Product (Y/N): N
• Initial Reporter Country: PA
• PMA/510(K) Number: K033003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: SCH08
• Device Catalogue Number: SCH08
• Device Lot Number: 200606166
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1