MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; CAUTERY - HIGH TEMP, FINE TIP

Catalog Number AA01

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The reporter initially sent an email requesting that someone contact them regarding "an adverse event that occurred while using the bovie cautery fine tip ref (b)(4)." no other details regarding the event were received.After repeated attempts to follow up for additional information, the reporter responded on stating: "please disregard.I do believe this was all related to user error.".

Manufacturer Narrative

The reporter initially sent an email requesting that someone contact them regarding "an adverse event that occurred while using the bovie cautery fine tip ref (b)(4)." after repeated attempts to follow up for additional information, the reporter responded on stating: "please disregard.I do believe this was all related to user error.".Additional attempts were made to get more details as to what occured, but we have received no further response.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 contains details regarding what happened, alleges any additional patient involvement, or need for corrective actions a follow up report will be submitted.

• Brand Name: BOVIE
• Type of Device: CAUTERY - HIGH TEMP, FINE TIP
• 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: andy ferrell ; 3034 owen drive; antioch, TN 37013 ; 6159645553
• MDR Report Key: 13062696
• MDR Text Key: 284710296
• Report Number: 3007208013-2021-00037
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 10607151011014
• UDI-Public: 10607151011014
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AA01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1