MAUDE Adverse Event Report: ARTHROCARE CORP. REFLEX ULTRA PTR COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EICA4835-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during turbinate reduction surgery, when the ablate foot penal was initially depressed, the ablate setting went to ¿0¿ and nothing occurred.A new wand was opened but the same issue occurred.Procedure was cancelled.No patient injuries were reported.
Additional Manufacturer Narrative
There was no relationship found between the returned device and the reported incident.Visual inspection under magnification shows no electrode wear with no manufacturing abnormalities visually observed with the returned device.The device was plugged into the controller and registered the correct defaults.The wand was then activated in a beaker of saline solution at the default and max settings and performed as intended.The complaint could not be verified and the root cause for this event could not be determined with confidence as the device performed as intended.It is possible that the connector block on the wand was not fully inserted into the controller display; therefore, causing the settings to not register.Other factors that could cause the device to not function is not having a sufficient amount of saline or intracellular fluid in order to maintain the formation of plasma.Factors unrelated to the manufacture or design of the device which could have contributed to the reported event is the controller; however, was not returned for evaluation.

• Brand Name: REFLEX ULTRA PTR COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8406503
• Report Number: 3006524618-2019-00135
• Device Sequence Number: 2327458
• Product Code: GEI
• UDI-Device Identifier: 00817470003871
• UDI-Public: 00817470003871
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2020
• Device Catalogue Number: EICA4835-01
• Device Lot Number: 2023370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/10/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1