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

Model Number	E15646
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting return of the reported device and/or additional information from the complainant to complete the evaluation.
Event or Problem Description
The complainant alleges, "during procedure, the device was not working properly, eschar was sticking to the electrode ball and tears away eschar that made cervix bled more.Suture was done.".
Additional Manufacturer Narrative
Multiple attempts were made to follow up with the customer to receive further information, however no further information about the complaint was able to be confirmed.A dhr review was completed for product e15646 with lot number x1021ux.There were no noted nonconformities during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specification from the manufacturer.Complaint was unable to be confirmed at this time, as no further information was able to be received by the customer.True root cause remains unknown.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.

• Brand Name: VALLEYLAB
• Common Device Name: BALL 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: 18899488
• Report Number: 3007208013-2024-00011
• Device Sequence Number: 7886682
• Product Code: HGI
• UDI-Device Identifier: 10607151009851
• UDI-Public: 10607151009851
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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
• Device Model Number: E15646
• Device Lot Number: X1021UX
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown