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

Model Number	AA03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the evaluation.
Event or Problem Description
The complainant alleges, "the aa03 with lot 0923y had the tip at the end break during use.No patient involvement.".
Event or Problem Description
The complainant alleges, "the aa03 with lot 0923y had the tip at the end break during use.No patient involvement.".
Additional Manufacturer Narrative
Per the customer, the customer was completing a nail trephination, when the cautery was heated for a few seconds, the wire broke near the tip.In the first incident, the wire melted to the patient's nail, but was able to be easily removed.The first cause tip broke while touching patient nail.The next two cautey tips broke with not touching anything.The complaint was unable to be confirmed as the product was unable to be returned for testing and pictures were unavailable.True root cause is unable to be determined with accuracy at this time.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: 19668393
• Report Number: 3007208013-2024-00033
• Device Sequence Number: 6835766
• Product Code: HQP
• UDI-Device Identifier: 00607151011031
• UDI-Public: 00607151011031
• 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
• 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: AA03
• Device Lot Number: 0923Y
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown