MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATOR II CONTROLLER 240V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EC8001-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coblator does not have the required efficiency for a turbinate reduction.After surgery it was sent to testing and it was found that the wands create less plasma than usual.It is unknown if there were any backup device or delay in the procedure.
Additional Manufacturer Narrative
The original reason to report this case was that, based on the initial information we received, there was not any back-up device available in the procedure; however, after an additional contact held with the complainant, it was revealed that the procedure was successfully completed without significant delay and using a s&n back-up device; and that the patient did not suffer any injury or adverse consequence.Based on the aforementioned information, the manufacturer has identified that this event should be re-evaluated for mdr reporting.The re-assessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
Event or Problem Description
It was reported that during a turbinate reduction the coblator does not have the required efficiency for a turbinate reduction.After surgery it was sent to testing and it was found that the wands create less plasma than usual.No back up device was available and a no significant delay was reported.
Additional Manufacturer Narrative
(b)(6).

• Brand Name: COBLATOR II CONTROLLER 240V
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8314623
• Report Number: 3006524618-2019-00080
• Device Sequence Number: 1578093
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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 Catalogue Number: EC8001-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 03/14/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 03/05/2019; 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1