MAUDE Adverse Event Report:; CAUTERY DEVICE

Catalog Number	DYNJ0337465F
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The account reported that a patient was burned from a flash fire due to pooled chloraprep under a patient's neck during a pace maker procedure.According to the customer, the high concentration of oxygen and alcohol fumes mixed with the cautery and caused a flash fire.No additional information is available.The sample was not returned for evaluation.A root cause cannot be determined at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.
Event or Problem Description
It was reported that during a surgical procedure, there was a flash fire that burned a patient's neck.

• Common Device Name: CAUTERY DEVICE
• MDR Report Key: 6947905
• Report Number: 1423395-2017-00025
• Device Sequence Number: 899545
• Product Code: OEZ
• UDI-Device Identifier: 10889942165346
• UDI-Public: 10889942165346
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Catalogue Number: DYNJ0337465F
• Device Lot Number: 17BB1573
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other