MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; HIGH FREQENCY DESICCATOR

Catalog Number	A942
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged that during homeostasis of the left eyelid ptosis surgery.The bipolar was activated and discharged from the tip.The patient's eyelashes burned due to the activation.During this procedure, the surgeon turns the eyelid inside out and shortens the eyelid muscles from the inside of the eyelid.There is possibility that the patient could have inflammation or burns over time, but there were no obvious burns confirmed immediately after the incident.The eyelid surgery was completed including suturing and the area around the left eye was treated with cooling after surgery.
Additional Manufacturer Narrative
The customer returned a bipolar forcep that was a product manufactured by bovie medical.However, the customer returned a942 generator as it was in use during the incident.The unit is being returned for testing and possible repair.A follow up report will be submitted with the results of the generator testing.This is the first complaint recorded of its kind.
Additional Manufacturer Narrative
Generator was returned for further testing, along with accessories, to service center on their rma 834000904 on 2/24/2023.Complaint not confirmed.All returned products functioned as necessary and passed specifications.It was noted that seals on the generator were pushed in (then replaced), however, it is not believed that these seals had any impact on the functionality of the generator.Reference attached repair report for further information.According to attached ifu for a942 - mc-55-239-001 revision 3: "danger: fire / explosion hazard - do not use the bovie® derm 941/942 in the presence of flammable materials"."the sparking and heating associated with electrosurgery can provide an ignition source.Observe fire precautions at all times.When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is performed." root cause is determined to be user error in operating the electrosurgical device very close to flammable material.Body hair/lashes are considered a flammable material.Therefore, when the bipolar became active in proximity to the eye lashes, the eye lashes became an ignition source for the burn to occur.Based on the information provided thus far, no further actions are required.This can be seen as the final report.If additional information is obtained that alleges additionally patient involvement or information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: HIGH FREQENCY DESICCATOR
• 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: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 16421958
• Report Number: 3007208013-2023-00008
• Device Sequence Number: 20264244
• Product Code: GEI
• UDI-Device Identifier: 10607151011175
• UDI-Public: 10607151011175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2023

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 Catalogue Number: A942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown