MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, INC. ACCU-TEMP® CAUTERY, HIGH TEMP

Model Number	8442000
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following investigation conclusion.
Event or Problem Description
On september 26th, 2024 bvi has been notified by fda about medical device report received via the medwatch program concerning bvi product.The uf/importer report # (b)(4) described a situation when a bovie pen was used during patient care and a spark ignited.Patient pulled his finger away immediately and the chucks pad burned some.No obvious signs of injury were noted.
Additional Manufacturer Narrative
Bvi quality assurance has followed its internal procedure to conduct the appropriate investigation of the complaint.The investigation included a review of current process controls and the device history record (dhr).All manufacturing operations were recorded; all signatures and dates were present, and the lot passed the required inspections.Unfortunately, the customer did not provide physical samples or pictures of the involved product, that would allow detailed evaluation of the situation described.However, according to the description provided by the customer, this type of incident may occur in situations where the device is used in an environment with an oxygen concentration greater than 21%.The device's instructions for use clearly specifies that the use of such equipment in environments with elevated oxygen levels may present an ignition hazard.It is therefore recommend to review the environmental conditions in which the device is being used, ensuring that all ifu instructions are followed to avoid similar incidents in the future.Complaint was acknowledged per customer information and added to bvi records.Bvi will continue to monitor any feedback from our customers and take appropriate action if an unfavourable trend is observed.

• Brand Name: ACCU-TEMP® CAUTERY, HIGH TEMP
• Common Device Name: ACCU-TEMP® CAUTERY, HIGH TEMP
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, INC.; 500 totten pond rd; 10 city point; waltham MA 02451 1916
• Manufacturer Contact: agnieszka drzewiecka ; valle del cedro no. 1520; parque industrial intermex; ciudad juarez chihuahua,, MA CP 32-5757 ; MX CP 3257575
• MDR Report Key: 20471331
• Report Number: 1211998-2024-00017
• Device Sequence Number: 12665726
• Product Code: HQP
• UDI-Device Identifier: 00886158010265
• UDI-Public: (01)00886158010265
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K771189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2025

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 Expiration Date: 03/17/2026
• Device Model Number: 8442000
• Device Catalogue Number: 8442000
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Unknown