MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVE; GENERATOR

Catalog Number	A2250
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was purchased prior to the acquisition of bovie medical to symmetry surgical.Based on the serial number, estimated around 2006-2007.Customer has been using product without issues for many years.Customer was using a 3m split return electrode with part number 9165 with lot 202506gr when the patient reported a tingling feeling under the pad.Customer was completing a vasectomy procedure, with the pad placed on the left thigh.Operation settings were around 15 coag/ 15 cut.Pictures were received from the customer of the pad, and some hair was found present on the pad.Complaint is confirmed.Root cause is believed to be a user error in not preparing the pad application site prior to apply pad.Hair should be removed prior to applying electrosurgical single use pads.This is the first complaint of its kind for this part number in a review of the last 2.5 years of complaints.This product is no longer being sold and has been replaced by a2350.= low.Based on the above information, no further actions are required and this can be seen as the final report.If additional information is obtained that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 information pertinent to the investigation, a subsequent follow up report will be submitted.
Event or Problem Description
The customer alleged that while using an a2250, the patient felt a tingling under the pad being used.The user had to stop the procedure twice to check under the pad which delayed the procedure.The a2250 was removed from the surgery and an aa03 - handheld cautery was used in its place.No further harm to the customer.

• Brand Name: BOVE
• 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: 17490385
• Report Number: 3007208013-2023-00040
• Device Sequence Number: 7253457
• Product Code: GEI
• UDI-Device Identifier: 10607151002784
• UDI-Public: 10607151002784
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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: A2250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2006
• 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