MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN SINUPLASTY SYSTEM; INSTRUMENT, ENT MANUAL SURGICAL

Model Number RSO616M

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

There was a defective sinus balloon.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o'brien drive; menlo park CA 94025
• MDR Report Key: 3831933
• MDR Text Key: 20460107
• Report Number: 3831933
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2014

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
• Device Operator: Physician
• Device Model Number: RSO616M
• Device Catalogue Number: RS0616M
• Device Lot Number: 130124B-CM
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR