MAUDE Adverse Event Report: ENTELLUS MEDICAL INC. XPRESS ULTRA; ENT DILATION SYSTEM

Model Number	MSB&LLF
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The xpress ultra ent dilation system, ref # (b)(4), lot # a15246 is battery powered by lithium ion unit and has no shut off.There is no action, switch, knob to turn the power off to the instrument.The scrub tech noticed the unit was hot after surgery.

• Brand Name: XPRESS ULTRA
• Common Device Name: ENT DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL INC.
• MDR Report Key: 7628796
• Report Number: MW5077978
• Device Sequence Number: 2512563
• Product Code: LRC
• UDI-Device Identifier: 00857326005123
• UDI-Public: (01)00857326005123(17)200420(10)
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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 Expiration Date: 04/20/2020
• Device Model Number: MSB&LLF
• Device Catalogue Number: ULF-106
• Device Lot Number: A15246
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2018
• 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: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 93