MAUDE Adverse Event Report: BOVIE MEDICAL CORP BOVIE; REPLACEMENT TIP

Model Number	A807
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported multiple lot numbers: lot# 012b and 0721h it is unknown at this time which one was involved in the incident.Additional information has been requested along with the product itself.This is the first complaint of its kind with (b)(4) tips sold.A follow up report will be submitted once new information is obtained or the device is evaluated.
Event or Problem Description
The customer alleged that while using the del1 device with the h121 tips, the tips are charring, bending, and breaking.The customer confirmed that the tip broke off into the patient and was removed with no other consquence or delay in surgery.
Additional Manufacturer Narrative
Symmetry was notified that the lot number involved in the incident is unknown and the product is not available.We were also notified that the customer has changed the process/handling of the tips and the issue is no longer occurring.It was confirmed on (b)(6)2022 that no further issues have occurred since the customer corrected their usage of the product.Root cause is determined to be user error.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or additional information pertinent to the investigation, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: REPLACEMENT TIP
• Manufacturer (Section D): BOVIE MEDICAL CORP; 5115 ulmerton road; clearwater FL 33760
• Manufacturer (Section G): BOVIE MEDICAL CORP; 5115 ulmerton corp; clearwater FL 33760
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013 ; 6159645290
• MDR Report Key: 15307088
• Report Number: 3007208013-2022-00036
• Device Sequence Number: 15074009
• Product Code: HGI
• UDI-Device Identifier: 00607151018078
• UDI-Public: 00607151018078
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: A807
• Device Catalogue Number: H121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown