MAUDE Adverse Event Report: ENTELLIS MEDICAL LO PROFILE MULTI-SINUS DILATION SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number LPLF-106

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

When preparing the case, functional endoscopic sinus surgery (fess) with balloon, the tech was checking the equipment for proper function.The syringe malfunctioned; "did not click two times when operating.".

• Brand Name: LO PROFILE MULTI-SINUS DILATION SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ENTELLIS MEDICAL; 3600 holly lane n suite 40; plymouth MN 55447
• MDR Report Key: 4696607
• MDR Text Key: 18922765
• Report Number: 4696607
• Device Sequence Number: 1
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: LPLF-106
• Device Lot Number: A5634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 65