MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS; INSTRUMENT, ENT MANUAL SURGICAL

Model Number RSP0616MFS

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Date 06/29/2017

Event Type  malfunction  

Event Description

Balloon would not hold water as needed.There appeared to be a hole in the balloon.

• Brand Name: RELIEVA SPINPLUS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 6837460
• MDR Text Key: 84326809
• Report Number: 6837460
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: RSP0616MFS
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 161130A-PC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2017
• 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
• Patient Age: 47 YR