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

Model Number	H121
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the bovie cautery replacement tips are breaking off.One tip broke off while in use and burned a patient during a vasectomy.The burn was not serious and did not require additional medical intervention.
Additional Manufacturer Narrative
The customer stated that "during a vasectomy, the cautery unit is activated for 1-2 seconds to make an entry point into the vas, then it is activated again a few seconds later for 2-3 seconds to cauterize the vas lumen.There is then a several minute break until the process is repeated on the second side.The clinical team confirmed that this device should not be used to create an entry point as it is a cauterizing device only.Based on this information, it can be determined that the tip is breaking due to user error.The dhr was reviewed with no noted nonconformities during manufacturing and processing of this product and lot number.All items were noted to be within manufacturing specifications from the manufacturing location.This is an isolated event with 94,210 individual tips sold since 2018.Based on the above information, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions, a follow up report will be submitted.This submission is passed due as we recently discovered that the original submission was not accepted due to an old version of esubmitter.

• 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 ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13538711
• Report Number: 3007208013-2021-00035
• Device Sequence Number: 20061238
• Product Code: GEI
• UDI-Device Identifier: 00607151071219
• UDI-Public: 00607151071219
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K945758
• 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): 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: H121
• Device Catalogue Number: H121
• Device Lot Number: 0820K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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