MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVE; IMA / ENT ELECTRODE BLADE

Catalog Number	ES37
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the guarded electrode tip insulation started to peel away / fragment during use with a potential for it to break off inside the patient.To this date, there has been no report of patient or user involvement.
Additional Manufacturer Narrative
We only have very limited information regarding this complaint case.We are continuing to follow up with the customer to obtain additional information.This is the second complaint of its kind within the last 2.8 years of complaint reviews on 4 eaches of products.In the same time period, we have sold 65825 eaches.0.0046% = low.A follow up report will be submitted once we have received additional information.
Additional Manufacturer Narrative
Customer was using product during an unknown procedure and operation when the physician stated the coating on the electrode was coming off.Customer confirmed there was no patient impact.Customer was asked multiple questions, and multiple follow ups were attempted, but no further information was able to be obtained.Complaint case is unable to be confirmed at this time.True root cause cannot be determined with accuracy without further information.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.

• Brand Name: BOVE
• Common Device Name: IMA / ENT ELECTRODE BLADE
• 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
• MDR Report Key: 17870322
• Report Number: 3007208013-2023-00048
• Device Sequence Number: 18042760
• Product Code: GEI
• UDI-Device Identifier: 10607151056374
• UDI-Public: 10607151056374
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K942986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: ES37
• Device Lot Number: 0423Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown