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

Model Number	ES10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user alleges that the customer was attempting to activate loop wire at 50/50 cut pure / coag fulgurate when the wire detached from the t-tube of the device making it not able to be used.The customer had 2 electrodes undergo this failure before the third device worked.The root cause is determined to be user error in operating the loop electrode at a very high power setting.According to the product ifu: - always use the lowest power setting that achieves the desired surgical effect.Use the active electrode for the minimum time necessary in order to reduce the possibility of unintended burn injury.- maximum listed power setting is 55w in pure cute/blend.Customer was using 50w pure cute/fulgurate.-loop electrodes are not designed for use in the coagulation mode.Do not activate the generator in coag while using a loop electrode.Loop breakage may result if additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.
Event or Problem Description
The complainant alleges, "the product es10 with lot 0922z broke during surgery.".

• Brand Name: BOVIE MEDICAL
• Common Device Name: ELECTRODE
• 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18866023
• Report Number: 3007208013-2024-00008
• Device Sequence Number: 3306257
• Product Code: HGI
• UDI-Device Identifier: 00607151056100
• UDI-Public: 00607151056100
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2024

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 Model Number: ES10
• Device Lot Number: 0922Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown