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

Model Number	231
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant alleges, "high temp cautery was catching fire".
Additional Manufacturer Narrative
The complaint was able to be confirmed via information from end user.Customer was activating the device for up to 30 seconds near the patient eye lid.(note - eye lid contains hair and hair is a flammable material.) root cause is determined to be user error in having an extended activation time and activating near a flammable material.Per the ifu: - warnings: do not use in presence of flammable gases/materials or oxygen rich environments.Fire could result.- the recommended duty cycle is 2 seconds on and 6 seconds off for a continuous time of no longer than 15 minutes.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): SYMMETRY SURGICAL INC.; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 19525505
• Report Number: 3007208013-2024-00025
• Device Sequence Number: 15328639
• Product Code: HQP
• UDI-Device Identifier: 10612479209029
• UDI-Public: 10612479209029
• 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
• Report Date (Section B): 06/12/2024

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: 231
• Device Lot Number: 0923Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown