MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; LOOP ELECTRODE

Catalog Number	ES43
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer gave the following information about the device: products were both from same lot number, 0121h.Product was inspected prior to surgery, however was not documented.The surgery was a leep procedure in area cervix.Customer was using the device in mode "pure cut at 50 watts" with unknown activation/resting intervals.Electrodes were used for 1.5-2 minutes.Note that per attached ifu, max power settings are 55 watts pure cut.Due to issue, customer used ball electrode to complete surgery.Patient was grounded successfully to grounding pad without complication.There was no injury or negative health consequence to occur due to the wire breaking.Customer stated return for further investigation is possible.Giving customer shipping label and rma to return products for further investigation (b)(6) 2022.Products were received through the rma room on (b)(6) 2022.Complaint was able to be confirmed for broken loop wire.Both returned products broke at the welding point of the wire to the t tube.Root cause is unable to be determined with accuracy at this time.However, it may be possible that : the extended activation of the electrode at a higher power setting led to a failure of the loop wire to t-tube weld.This was an isolated incident of a bad weld on the device from the manufacturing of the device.(this is the first complaint of its kind).This is an isolated event, and we will continue to track and trend for future complaintss.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 follow up report will be submitted.
Event or Problem Description
The customer alleged that the electrode wire broke during a procedure for two devices of the same lot.The broken product was able to be removed without injury to the patient, but it did cause a delay in surgery.

• Brand Name: BOVIE
• Common Device Name: LOOP ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton rd; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15495921
• Report Number: 3007208013-2022-00040
• Device Sequence Number: 6068042
• Product Code: GEI
• UDI-Device Identifier: 10607151056435
• UDI-Public: 10607151056435
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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: 01/01/2025
• Device Catalogue Number: ES43
• Device Lot Number: 0121H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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