MAUDE Adverse Event Report: BOVIE MEDICAL CARDINAL HEALTH; LOW TEMP CAUTERY

Catalog Number	65410-010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
4 each with lot number 0721l were returned for evaluation and further testing.From visual evaluation three of the cauteries tested have a faint red glow when activated and one cautery has a bright red glow when activated.Root cause is determined to be a low charge on the battery in select units that the customer received.There has been a total of 77,680 sold with 3 total complaints recorded since 2016.Due to the low risk and low complaint rate, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or need for corrective actions a follow up report will be submitted.
Event or Problem Description
The customer alleged that the low temp cautery takes one minute to get red hot.This delay in getting hot occurred during a critical point in the surgery when timing is crucial due to the manipulation of tissue along with the implant.The patient was not harmed,.

• Brand Name: CARDINAL HEALTH
• Common Device Name: LOW TEMP CAUTERY
• Manufacturer (Section D): BOVIE MEDICAL; 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 ; 6159645290
• MDR Report Key: 15234183
• Report Number: 3007208013-2022-00034
• Device Sequence Number: 6446718
• Product Code: GEI
• UDI-Device Identifier: 50885380001435
• UDI-Public: 50885380001435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2022

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: 07/01/2025
• Device Catalogue Number: 65410-010
• Device Lot Number: 0721L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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