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

Model Number RSP0616MFS

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Event Description

During procedure using the acclarent relieva spinplus (ref # rsp0616mfs, lot 190515a-pc) the telescoping light carrier stopped retracting.While trying to retract the light carrier, the mechanism in the handle broke.The broken sinus balloon was handed off and replaced with another device without incident.No patient harm.

• Brand Name: RELIEVA SPINPLUS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr.; suite 200; irvine CA 92618
• MDR Report Key: 9962082
• MDR Text Key: 187733279
• Report Number: 9962082
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSP0616MFS
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 190515A-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: 03/13/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 99