MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; REPLACEMENT TIP

Catalog Number	H104
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that during a vasectomy, the replacement cautery tip keeps falling out into the surgical field.Delays during local anesthesia and anesthesia with nitrous occurred as burnt or non-working tips needed to be replaced.
Additional Manufacturer Narrative
After reviewing with the customer, it was determined that the customer is using the h104 (low temp elongated tip) with a high temperature cautery handle.Complaint confirmed.Root cause is determined to be user error in not selecting the correct tip.There has been a total (b)(4) sold of all lots with 2 additional complaints recorded.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 alleges any additional patient involvement or additional information pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: REPLACEMENT 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: brandi meath ; 5115 ulmerton road; clearwater, FL 33760 ; 6159645290
• MDR Report Key: 17623825
• Report Number: 3007208013-2023-00042
• Device Sequence Number: 15279316
• Product Code: GEI
• UDI-Device Identifier: 10607151071049
• UDI-Public: 10607151071049
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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: H104
• Device Lot Number: 0321G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown