MAUDE Adverse Event Report: BOVIE MEDICAL CORP SMOKE SHARK; SMOKE EVACUATION

Catalog Number	SE02-220
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that the smoke shark stopped working 20 minutes into the procedure.It was confirmed that the procedure had to be canceled and rescheduled.
Additional Manufacturer Narrative
Product was purchased through zinnanti surgical design on 9/22/2023 under our order number (b)(4) and exported to end user through an unknown order number or date.Customer has been able to use the device successfully for some time, however, now gets random shut downs on the unit after about 20 mins of use.Customer was given rma and shipping label to return the product for repair and evaluation on.A supplemental report will be submitted once the device has been evaluated.
Additional Manufacturer Narrative
Customer was offered an rma and shipping label to return the product for repair and evaluation, but chose not to pursue the repair.Customer was followed up with about this repair on 12/20/2023, 01/03/2024, 01/10/2024, and 01/17/2024 - however, customer did not continue with the repair.Complaint confirmed from pictures and information received from the customer.True root cause is unable to be determined as customer chose to not return the device for repair or evaluation.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 informaiton pertinent to the investigation, a subsequent follow up report will be submitted.

• Brand Name: SMOKE SHARK
• Common Device Name: SMOKE EVACUATION
• 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: 18436848
• Report Number: 3007208013-2024-00002
• Device Sequence Number: 15361731
• Product Code: FYD
• UDI-Device Identifier: 10607151008304
• UDI-Public: 10607151008304
• Combination Product (Y/N): N
• Initial Reporter Country: NI
• PMA/510(K) Number: K924732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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 Catalogue Number: SE02-220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown