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

Catalog Number SE02-220

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 331813443
• Report Number: 3007208013-2024-00002
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10607151008304
• UDI-Public: 10607151008304
• Combination Product (y/n): N
• Reporter Country Code: NI
• PMA/PMN Number: K924732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: SE02-220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1