MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; CAUTERY

Catalog Number	AA01
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer was not able to provide the lot number.As a result, the device history records for the batch were not able to be reviewed.Additionally, pictures were not provided, and the device is not available for return.This is the first complaint received regarding the tip bending during use.Based on the information provided by the customer, it is likely that the tip bent due to an external force during use.This can be seen as the final report.If additional information is obtained that provide any additional information pertinent to the investigation, a supplemental report will be submitted.
Event or Problem Description
The customer alleged that during a cardiovascular procedure the tip of the cautery broke off.The surgeon stated that there was no external force applied to the tip.On 12/20/2023 additional information was received that indicates that the tip of the cautery did not detach from the device.It was confirmed to be deformed compared to the original condition.
Additional Manufacturer Narrative
Correction - lot number was provided by the customer.On 12-20-2023 an update was provided from the distributor - it was confirmed that the condition of the reported cautery in the initial information provided was incorrect.The tip was not been detached from the brass pole but deformed comparing to the original configuration.It seems that the cautery tip have been put under some external force.Customer was attempting to use product when the tip deformed.According to information from the reporter, it is believed the user applied force to the cautery when activated, allowing the tip to become deformed.Complaint confirmed.Root cause is determined to be user error in not following the ifu.According to mc-23009 rev 10 - " applying excessive force on the cautery during use may cause tip to bend or break" a dhr review was completed for product aa01--- with lot number 0323u.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.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: BOVIE
• Common Device Name: CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18432129
• Report Number: 3007208013-2023-00063
• Device Sequence Number: 20869359
• Product Code: GEI
• UDI-Device Identifier: 10607151011014
• UDI-Public: 10607151011014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: AA01
• Device Lot Number: 0323U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown