MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS LOPROFILE MULTISINUS DILATION SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number LPLF-106

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

The light for the xpress loprofile multi dilation system by entellus medical did not work when strip was pulled for activation.

• Brand Name: XPRESS LOPROFILE MULTISINUS DILATION SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 holly lane n suite 40; plymouth MN 55447
• MDR Report Key: 5513266
• MDR Text Key: 40749707
• Report Number: 5513266
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: LPLF-106
• Device Lot Number: A56H6
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1