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

Lot Number 1217E

Device Problem Fire (1245)

Patient Problem Burn, Thermal (2530)

Event Date 01/25/2019

Event Type  malfunction  

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 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
• Type of Device: CAUTERY HIGH TEMP
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 8675994
• MDR Text Key: 147326544
• Report Number: 3007208013-2019-00005
• Device Sequence Number: 1
• Product Code: HQP
• UDI-Device Identifier: 00607151011017
• UDI-Public: 607151011017
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K121441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1217E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1