MAUDE Adverse Event Report: BOVIE MEDICAL CORP ARGENT MCKESSON; GENERATOR

Catalog Number	22-A952
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit has been received at the repair facility.A dhr review was completed for product 22-a952 with serial number (b)(6) and 22-a942 with serial number (b)(6).There were no noted nonconformities during manufacturing and processing of this product and serial numbers.All items were noted as within manufacturing specification from the manufacturer.This is the first complaint of its kind for this part number in review of the last 2.5 years of complaints = low.Once the evaluation is complete, a follow up response will be submitted.
Event or Problem Description
The customer alleged that the devices stopped working mid-procedure.When the procedure was interrupted the surgeon was not able to remove all of the tissue that there were attempting to remove.There was no harm to the patient.
Additional Manufacturer Narrative
The procedure was stopped and the patient was not able to have all the tissue that was intended to be removed, removed.The customer was using a grounding pad when using the 22-a952.The customer was using the handpiece with multiple types of electrodes with unknown part numbers (loop electrodes and ball electrodes) at 35-40 watts coagulation setting.Customer was offered rma and shipping label to return the 22-a952 for further review and testing on product was received through the repair facility and repair was completed on (b)(6) 2023 "issue not confirmed for turned off during use.The unit did not turn off or have any issues during arc testing or burn-in performed in repair.Outputs were monitored during burn-in with no issue or shutdowns found.The unit was tested at 90v, 120v and 264v." complaint could not be confirmed at this time.True root cause is unable to be determined with accuracy at this time.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 involvement or additional informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: ARGENT MCKESSON
• Common Device Name: GENERATOR
• 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: 17514693
• Report Number: 3007208013-2023-00041
• Device Sequence Number: 5587211
• Product Code: GEI
• UDI-Device Identifier: 20612479212927
• UDI-Public: 20612479212927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2023

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 Catalogue Number: 22-A952
• Device Lot Number: MKE0721007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown