MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; NERVE LOCATOR

Model Number	0003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr for the lot numbers provided were reviewed.There were no noted noncomformities during manufacturing and processing of this product and lot number.All items were noted as within manufacturing specification from the manufacturer.The device functioned as intended through testing, but did not locate the patient's nerve.The patient had underlying conditions that could of affected the product ability to locate the nerves.However, the customer was not able to provide enough information to determine a true root cause.There has been a total of (b)(4) sold since 2016 with one additional complaints recorded for a similar occurrence.The equates to a (b)(4) complaint rate and is determined to be low.Based on the above information, this can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.
Event or Problem Description
The nerve stimulator would not stimulate the nerve during a left modified radical neck dissection when nerve was isolated by the surgeon.The stimulator was replaced the second device did not work.The surgical tech checked both devices, the tips touched, and the light activated, but neither would stimulate the nerve.There was no injury to the patient on a slight delay in the procedure.

• Brand Name: BOVIE
• Common Device Name: NERVE LOCATOR
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760
• MDR Report Key: 11069533
• Report Number: 3007208013-2020-00040
• Device Sequence Number: 3700789
• Product Code: ETN
• UDI-Device Identifier: 00607151000035
• UDI-Public: 00607151000035
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K905045
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

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: 12/01/2021
• Device Model Number: 0003
• Device Catalogue Number: 0003
• Device Lot Number: 1219E
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1