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

Model Number MSB&LLF

Device Problems Component Missing (2306); Failure to Shut Off (2939); Temperature Problem (3022)

Patient Problem No Information (3190)

Event Date 06/19/2018

Event Type  Injury  

Event 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
• Type of Device: ENT DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL INC.
• MDR Report Key: 7628796
• MDR Text Key: 112150654
• Report Number: MW5077978
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00857326005123
• UDI-Public: (01)00857326005123(17)200420(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 93