MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGH TEMP CAUTERY

Model Number	AA01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was purchased from an unknown order number through our distributor.The customer stated that the cautery was activated for 5-6 seconds at a time with resting cycles of 5 seconds.The cautery was used on 4 different mice for a total of 30 seconds including resting and activation times.The customer stated that the oxygen present at the surgical site caused the fire to spread rapidly.The surgeon received minor burns on the hands and was able to recover without hospitalization.The root cause has been determined to be human error.Most likely from the customer not following the proper duty cycles, reuse of the cautery, and having flammable material close to the cautery activation site.The ifu that is received with the item states the following: do not use in the presence of flammable gases/materials or in oxygen rich environments.Fire could result.This medical device cannot be effectively cleaned and or sterilized by the user and is therefore not safely reused.The recommended duty cycle is 2 seconds on and 6 seconds off for a continuous time of no longer than 15 minutes.The user was informed of the duty cycles and given the ifu for review.A dhr review was completed for the reported lot number.There were no noted nonconformities during manufacturing and processing of this product and lot numbers.All items were noted as within manufacturing specification from the manufacturing location.There has been a total of (b)(4) cauteries sold since 2016 with one additional complaint recorded for a similar occurrence.((b)(4) complaint rate).Based on the above information no further actions are required and this can be seen as the final report.If additional information is obtained that alleges any additional patient or user involvement or any need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The customer alleged that during a rodent surgery the high temp cautery sparked and caused a fire.There was no lab personnel injured in the process.

• Brand Name: BOVIE
• Common Device Name: HIGH TEMP 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 13538466
• Report Number: 3007208013-2021-00029
• Device Sequence Number: 19901550
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 00607151011017
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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
• Operator of Device: Other
• Device Expiration Date: 02/01/2023
• Device Model Number: AA01
• Device Catalogue Number: AA01
• Device Lot Number: 0219D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown