MAUDE Adverse Event Report: BOVIE MEDICAL CORP. BOVIE MEDICAL; CAUTERY

Model Number AA01X

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The user alleges that they were attempting to use the aa01x to cut open an ingrown toe nail to release pressure.The root cause is determined to be user error by ,is-using the device by attempting to cut/puncture.According to the product ifu: -applying excessive force on the cautery during use may cause tip to bend or break.-bovie® cautery devices are used for stopping small bleeders in hemostasis and other similar use.If additional information is obtained that is pertinent to the investigation or provides additional details a follow-up report will be provided.Until such time, this can be seen as the final report.

Event Description

The complainant alleged, "we were using a pen tip cautery to release pressure on an injured toenail when the cautery tip broke on 3 units.The 4th unit worked without breaking.All units were the same type (ref#aa01x).The patient was not injured in any way, it just took longer to perform the procedure.".

• Brand Name: BOVIE MEDICAL
• Type of Device: CAUTERY
• 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: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18866502
• MDR Text Key: 337226715
• Report Number: 3007208013-2024-00009
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 00607151008956
• UDI-Public: 00607151008956
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2024

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 Model Number: AA01X
• Device Lot Number: 0923X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1