MAUDE Adverse Event Report: SYMMETRY SURGICAL INC BOVIE; HIGH FREQUENCY GENERATOR

Model Number	IDS-310
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the generator manual, this type of unit is not to be used in oxygen rich areas as it can increase the risk for fire and explosion hazards.However, because the unit is letting of unusual sparks during testing, the device will be sent to our repair facility for full diagnostics and testing.There has been a total of (b)(4) sold since 2016 with no additional complaints recorded for this occurrence.
Event or Problem Description
An ids-310 unit is generating a spark that is not normal.It had to be withdrawn from the surgery room as since there was fire in surgery room, resulting in a burn to the patient.The fire was caused by a spark that came into contact with the oxygen.
Additional Manufacturer Narrative
After multiple attempts to reach out to the customer, the unit involved in the procedure has not been returned for evaluation and repair and no response has been received from the customer.Based on this information, a true root cause cannot be determined.This can be seen as the final report; if additional information is obtained that alleges any additional information, patient involvement, or need for corrective actions, a follow up report will be submitted.

• Brand Name: BOVIE
• Common Device Name: HIGH FREQUENCY GENERATOR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 9249898
• Report Number: 3007208013-2019-00034
• Device Sequence Number: 11258984
• Product Code: GEI
• UDI-Device Identifier: 10607151008946
• UDI-Public: 10607151008946
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: KI34054
• 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,Followup
• Report Date (Section B): 03/30/2020

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: IDS-310
• Device Catalogue Number: IDS-310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1