MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION BOVIE; UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Model Number AA05

Device Problem Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Narrative from staff: the device is used in bentall procedures to sow the coronary "buttons" onto the aortic tube graft.The first eye cautery room staff opened was not operating well, appeared as if you turned on a flashlight and watched it dim as the battery slowly dies.The second one that was opened worked for the surgeon briefly, then also started acting as if the battery was dying.Staff opened a third, which acted very similarly to the first and therefore, was not used.The surgeon ended up having to use an alternative means to create an opening in the tube graft for the coronary buttons, which was not ideal.All three of these devices have the same lot numbers.

• Brand Name: BOVIE
• Type of Device: UNIT, CAUTERY, THERMAL, BATTERY-POWERED
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton rd; clearwater FL 33760
• MDR Report Key: 14914169
• MDR Text Key: 295231174
• Report Number: 14914169
• Device Sequence Number: 1
• Product Code: HQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2022

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
• Device Operator: Health Professional
• Device Model Number: AA05
• Device Catalogue Number: AA05
• Device Lot Number: 0220K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male
• Patient Weight: 77 KG