MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOVIE; CAUTERY HIGH TEMP

Lot Number	1217E
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was not permanently harmed, a burn occurred with possible scarring.(b)(4).The batch records for the lot number provided was reviewed for any non-conformities.The device history record confirmed that items were within specification prior to shipping.The customer will not be returning the device for evaluation, as it is being held in their risk department, therefore a true root cause could not be determined.Based on the information above and the investigation that could be completed, this is being seen as an isolated event with no further actions necessary.This report can be seen as the final report.If additional information is obtained that alleges any other patient involvement or corrective actions a follow-up report will be submitted.
Event or Problem Description
The customer alleged that during a surgery meant to remove a conjunctival papillae injury, the cautery used to coagulate the small vein became hot in the tip.When it came close to the area that was being treated, a flame occurred that burned the patient's eyelashes and surrounding areas with subsequent scalding.

• Brand Name: BOVIE
• Common Device Name: CAUTERY HIGH TEMP
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 8675994
• Report Number: 3007208013-2019-00005
• Device Sequence Number: 11195023
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 607151011017
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 1217E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 06/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1