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

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

The subject acclarent device was not used for a patient procedure.The subject device is pending return for evaluation.When the product is returned and tested, a supplemental report will be filed.Acclarent will continue to monitor this phenomenon for trending purposes.

Event Description

Acclarent was informed of an event in which the sterile package of an acclarent relieva spin was not fully sealed.It was reported that when preparing for a procedure, the staff noticed that the package was already open on the left corner, but the rest of the sleeve pack was intact and sealed.The package was opened completely by the customer, and the device was removed, but the product was not used during the procedure.

• Brand Name: RELIEVA SPIN SINUPLASTY SYSTEM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 1525-b o¿brien dr; menlo park CA
• Manufacturer Contact: joaquin kurz ; 1525-b o¿brien dr; menlo park, CA 94025 ; 9497899383
• MDR Report Key: 5213435
• MDR Text Key: 30856984
• Report Number: 3005172759-2015-00017
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RS0616F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1