MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGHT TEMP CAUTERY

Catalog Number	AA21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mw5114839 was received through the fda.We have attempted to contact the customer with no response yet.We will continue to try and contact the customer so an investigation can take place.This is the first complaint recorded for this occurrence with (b)(4) sold of all lots.A follow up report will be submited once we have additional information.
Event or Problem Description
During a vasectomy it was noticed by the md while heating up that the wire seperated from the tip and was on.It was then removed with no harm to the patient.
Additional Manufacturer Narrative
The lot number was not reported, therefore there is no ability to review records.Customer purchased product on multiple order numbers through an unknown distributor.Customer was contacted on multiple occasions via phone and email, but no response was ever received.Reaching out to customer with questions (b)(6) 2023 followed up (b)(6) 2023 and (b)(6) 2023 and (b)(6) 2023 and (b)(6) 2023 called and left voice mail (b)(6) 2023 and (b)(6) 2023.No response was ever able to be received.Complaint was unable to be confirmed.True root cause is unable to be determined without further information.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: HIGHT TEMP CAUTERY
• 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16559250
• Report Number: 3007208013-2023-00011
• Device Sequence Number: 20259780
• Product Code: GEI
• UDI-Device Identifier: 10607151011212
• UDI-Public: 10607151011212
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: AA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown