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

Catalog Number	ES39
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the insulation failed on the electrode and caused a burn to the patient.
Additional Manufacturer Narrative
End user gave the following information about use of the device on 8/29/2022: electrode was used with a pencil from shuyou, ref #(b)(4).This was the first use of the device, out of the pouch.No inspection was documented.The original electrode received with the pencil was used when the es39 had issue.No eschar was present, and the patient was grounded with a grounding pad.There was: no break in-two of instrument, no delay in treatment, no death or serious injury to patient, no medical intervention, no instrument stress.Additional information was requested regarding power setting and the device is being returned for evaluation.A follow up report will be submitted after additional information is received or the device is evaluated.This is the first complaint recorded for this occurrence.
Additional Manufacturer Narrative
The customer is unable to provide further information about the power settings or use of the device beyond what was descibed.The customer's complaint was confirmed through pictured provided and through product return.However, due to lack of information provided we were unable to determine root cause.This is first complaint we have received of 63,375 units we have sold.This is an isolated event.This can be seen as the final report unless additional information is provided that alleges additional patient involvement or a need for corrective action.

• Brand Name: BOVIE
• Common Device Name: BLADE ELECTRODE
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton corp; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15411519
• Report Number: 3007208013-2022-00038
• Device Sequence Number: 6744250
• Product Code: GEI
• UDI-Device Identifier: 10607151056398
• UDI-Public: 10607151056398
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 09/13/2022

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: 05/01/2024
• Device Catalogue Number: ES39
• Device Lot Number: 0520H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown