MAUDE Adverse Event Report: ENTELLUS MEDICAL ENTELLUS XPRESS MULTI-SINUS DILATION TOOL; INSTRUMENT, ENT MANUAL SURGICAL

Model Number MSB&LLF

Device Problems Overheating of Device (1437); Inadequate Lighting (2957)

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

Event Date 06/02/2016

Event Type  malfunction  

Event Description

Operating room reports the surgeon was performing a functional endoscopic sinus surgery and was using an entellus multi-sinus dilation system (balloon) to dilate the sinuses.The light went out and the handle got warm.A second balloon was obtained.

• Brand Name: ENTELLUS XPRESS MULTI-SINUS DILATION TOOL
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 hollly lane north suite 40; plymouth MN 55447
• MDR Report Key: 5700268
• MDR Text Key: 46574952
• Report Number: 5700268
• 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: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: MSB&LLF
• Device Catalogue Number: LPLF-106
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2016
• 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
• Treatment: NOT KNOWN TO REPORTER.