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

Model Number	AA01
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
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
Received via fda's medsun program (report number: (b)(4)).The complainant alleges, "during a pediatric surgery, the patient was masked down for a lysis of penile adhesion.When the surgeon used the cautery high temp fine tip bovie it took a minute to activate and heat up.Once it warmed up enough, the surgeon started the procedure.The first assist student noticed the raytec sponge in their hand started turning black and felt warm.They placed the raytec on the mayo stand and an ember formed and caught on fire.The surgical tech tossed the raytec on the floor to avoid further spread.The fire was them put out safely with no harm to the patient or others.".
Additional Manufacturer Narrative
Awaiting additional information and/or return of the reported device to complete the evaluation.Supplemental report 001 - updated block h10 per fda request.
Event or Problem Description
Received via fda's medsun program (report number: (b)(4)).The complainant alleges, "during a pediatric surgery, the patient was masked down for a lysis of penile adhesion.When the surgeon used the cautery high temp fine tip bovie it took a minute to activate and heat up.Once it warmed up enough, the surgeon started the procedure.The first assist student noticed the raytec sponge in their hand started turning black and felt warm.They placed the raytec on the mayo stand and an ember formed and caught on fire.The surgical tech tossed the raytec on the floor to avoid further spread.The fire was them put out safely with no harm to the patient or others.".
Event or Problem Description
Received via fda's medsun program (report number: (b)(4)).The complainant alleges, "during a pediatric surgery, the patient was masked down for a lysis of penile adhesion.When the surgeon used the cautery high temp fine tip bovie it took a minute to activate and heat up.Once it warmed up enough, the surgeon started the procedure.The first assist student noticed the raytec sponge in their hand started turning black and felt warm.They placed the raytec on the mayo stand and an ember formed and caught on fire.The surgical tech tossed the raytec on the floor to avoid further spread.The fire was them put out safely with no harm to the patient or others.".
Additional Manufacturer Narrative
The complaint was able to be confirmed based on the information provided in the medwatch report.Root cause is determined to be user error in handling of device: per the device's ifu (mc-23009 rev 10) - do not use in the presence of flammable gases/materials or in oxygen rich environments.Fire could result.- cautery produces heat in excess of 1000 degrees f, which can cause burns or fire from misuse - cautery tip will remain hot immediately after deactivation and may cause inadvertent burns to user or patient.- always retain the cover cap and replace it on the cautery when not in use.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: 19892540
• Report Number: 3007208013-2024-00037
• Device Sequence Number: 7104172
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: AA01
• Device Lot Number: 0322Z
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 07/12/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/05/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown