MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; CAUTERY

Model Number	AA05
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer is not aware of: the storage condition of the devices.How products were transported to facility? (1 eaches or case).If the product was inspected prior to use, what material of graft the cautery was intended to cauterize? how many devices have been used by this facility before? if the tip of the cautery was wet at the time of activation, where the graft was being cauterized (inside body or external)? how long the cautery was activated? pictures were unavailable at time of questioning.Rma was given to customer to return the product in question on (b)(6) 2022.There has been a total of 21 complaints for the cautery not heating up with 192,910 sold of all lots (b)(4).A follow up report will be submitted once the device has been returned and we are able to evaluate.
Event or Problem Description
The customer alleged that the cautery was being used in bentall procedures to sow the coronary "button" to the aortic graft.The first eye cuatery the room staff opened was not operating well, it appeared as if you turned on a flashlight and watched it dim as the battery slowly died.The second one that was opened worked for the surgeon briefly, then also started acting as if the battery was dying.Staff opened a third, which acted very similarly to the first and second, therefore it was not used.The surgeon ended up having to use an alternate means to create an opening in the tube graft for the coronary buttons, which was not ideal.
Additional Manufacturer Narrative
Product was received through the rma room on 8/18/2022 - 3 out of 5 of the returned tips did not have the heating tip, and was more than likely removed by the facility by following the ifu after the procedure - testing for voltage at the tip was not possible for the 3 returned devices without tips - however, 2/5 eaches of unused cauterys were also returned - voltage was measured at the tip to find: - 1.78v - 1.76v - using formula for correlation of voltage at tips to temperature at the tips from vp-0147 y=(710.82*(voltages)) + 948.83 - 1.78v = 2214f - 1.76v = 2200f according to above data, product returned with tips were in specification.Further testing for used cautery devices without tips was completed by measuring the voltage of the batteries alone, outside the cautery assembly.2.864v, 3.061v, and 3.099v were values obtained from the battery packs.According to specification for in-process check of aa05, sp-18767 revision 9, voltage readings should be 3.1v at time of manufacturing.- due to devices being used, it is believed these devices may have had the correct voltage on the batteries before use.The complaint was unable to be confirmed at this time.Based on the investigation, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or information that is pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15123086
• Report Number: 3007208013-2022-00033
• Device Sequence Number: 12593575
• Product Code: GEI
• UDI-Device Identifier: 00607151011055
• UDI-Public: 00607151011055
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: AA05
• Device Catalogue Number: AA05
• Device Lot Number: 0220K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2020
• 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