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

Model Number	EICA6895-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the wand was failing.The procedure was successfully completed with up to 30 minutes of delay using a competitor device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the turbinator coblator ii wand, used in treatment, was returned for evaluation.From the information provided, ¿during surgery, the wand was failing." a relationship between the device and reported incident was not established.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures.Visual inspection shows moderate electrode erosion and contamination on the device tip.The device was plugged into the controller and registered settings that indicate the end of useful life for the device.The use-limiting feature was then by-passed and the wand was activated in saline solution at the default and max settings on the controller and performed as intended.Functional evaluation revealed that the saline line performed as intended.Suction performed as intended.The complaint was not verified and the root cause could not be determined with confidence.There are several factors that could cause the device to fail such as: 1.Not having sufficient saline outflow in order to maintain the formation of plasma or possibly not having sufficient suction which decreases the functionality of the device.2.The device may have been connected and disconnected multiple times before use, causing the muls to trigger, thus disabling all functionality of device.This intended behavior may have been interpreted as a non-functional device.3.There may have been an issue with the connection between the device and the rest of the system (i.E.An incomplete connection).No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TURBINATOR COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9548885
• Report Number: 3006524618-2020-00004
• Device Sequence Number: 16759601
• Product Code: GEI
• UDI-Device Identifier: 00817470005240
• UDI-Public: 00817470005240
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122652
• 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): 03/26/2020

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: 10/25/2021
• Device Model Number: EICA6895-01
• Device Catalogue Number: EICA6895-01
• Device Lot Number: 2022599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1