MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; CAUTERY

Model Number	AA21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant alleges, "the metal tip on the end of the cautery high temp tool is very flimsy and has been breaking off (or burning itself out) during vasectomy procedures.He has had to use 2 or 3 items per procedure, in the past one item has been used.".
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the investigation.
Event or Problem Description
The complainant alleges, "the metal tip on the end of the cautery high temp tool is very flimsy and has been breaking off (or burning itself out) during vasectomy procedures.He has had to use 2 or 3 items per procedure, in the past one item has been used.".
Additional Manufacturer Narrative
Two new/unused products were returned from the customers box for testing.The devices were heated per ifu instructions of 2 seconds on with 6 seconds off.As an extreme case: the device was heated for 2 seconds and then touched against a hard metal instrument.(product is intended for pinpoint coagulation).The device remained hot for the duration of the touch, did not bend when touching the device while heated, and then was released and cooled appropriately.Complaint could not be confirmed at this time.This is believed to be an incident of accidental user damage to the device, either through extended activations or excessive force being applied to the fragile tip.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.

• Brand Name: BOVIE MEDICAL
• Common Device Name: 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19996802
• Report Number: 3007208013-2024-00039
• Device Sequence Number: 15254249
• Product Code: HQP
• UDI-Device Identifier: 00607151011215
• UDI-Public: 00607151011215
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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
• Device Model Number: AA21
• Device Lot Number: 1023Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown