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

Model Number	AA01X
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant alleges the aa01x was able to be activated while the cap was engaged; "replaced cap as one is supposed to do but wasn't aware that it can easily press the operating button down and keep the bovie on and hot.Noted by nurse several minutes later as it was starting to melt on the tray.".
Additional Manufacturer Narrative
The complaint was able to be confirmed based on information from the end user.Customer stated that when the cover cap was re-applied after use, the switch was pushed under the locking mechanism of the cover cap - hence leaving the button pressed down and activated.(switch should be above locking mechanism of cautery to prevent inadvertent activations).Root cause is determined to be an isolated case of user error.Per the ifu - customer should be removing the tip prior to putting the cover cap back on - which in turn breaks the circuit and prevent further activations.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.

• 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: 19950129
• Report Number: 3007208013-2024-00038
• Device Sequence Number: 21046926
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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 Model Number: AA01X
• Device Lot Number: 0923Z
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown