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

Model Number RSP0616MFS

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/23/2019

Event Type  malfunction  

Event Description

Staff reported to the charge nurse that the wire of the device would not slide properly and that it was "sticking".Device was removed from service and replaced with a new sterile supply.The device was given to materials management to handle a return to the manufacturer.

• Brand Name: RELIEVA SPINPLUS
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr.; irvine CA 92618
• MDR Report Key: 9659244
• MDR Text Key: 177374704
• Report Number: 9659244
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031232389
• UDI-Public: (01)10705031232389
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSP0616MFS
• Device Catalogue Number: RSP0616MFS
• Device Lot Number: 190509A-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5475 DA
• Patient Weight: 59