MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; CAUTERY - HIGH TEMP, FINE TIP

Catalog Number	AA01
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter initially sent an email requesting that someone contact them regarding "an adverse event that occurred while using the bovie cautery fine tip ref (b)(4)." no other details regarding the event were received.After repeated attempts to follow up for additional information, the reporter responded on stating: "please disregard.I do believe this was all related to user error.".
Additional Manufacturer Narrative
The reporter initially sent an email requesting that someone contact them regarding "an adverse event that occurred while using the bovie cautery fine tip ref (b)(4)." after repeated attempts to follow up for additional information, the reporter responded on stating: "please disregard.I do believe this was all related to user error.".Additional attempts were made to get more details as to what occured, but we have received no further response.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that contains details regarding what happened, alleges any additional patient involvement, or need for corrective actions a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: CAUTERY - HIGH TEMP, FINE TIP
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer Contact: andy ferrell ; 3034 owen drive; antioch, TN 37013 ; 6159645553
• MDR Report Key: 13062696
• Report Number: 3007208013-2021-00037
• Device Sequence Number: 4857906
• Product Code: HQP
• UDI-Device Identifier: 10607151011014
• UDI-Public: 10607151011014
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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 Catalogue Number: AA01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown