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

Model Number	AA01X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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 33760
• Manufacturer Contact: steven fox ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 18866502
• Report Number: 3007208013-2024-00009
• Device Sequence Number: 8294926
• Product Code: HQP
• UDI-Device Identifier: 00607151008956
• UDI-Public: 00607151008956
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AA01X
• Device Lot Number: 0923X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown