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

Model Number	EICA6895-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopic procedure, the "turbinator coblator ii" presented a red alarm.The procedure was successfully completed without delay with a change in the surgical technique.No further 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
The reported device, used in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.A review of the device history records for the reported lot number showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolate event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found that mishandling can result in device damage.Visual inspection of the device showed minimal erosion of the electrode screen and contamination around the tip.The device was plugged into the controller and registered settings (0,3) 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.The suction line was tested and saline flowed as intended.The complaint was confirmed and the root cause was determined to be reuse of a single use device.Factors that could have contributed to the reported event include: not having sufficient saline in order to maintain the formation of plasma, inadequate suction, device reaching its end of life, or the wand or foot control connector becoming disconnected from the controller display.Factors unrelated to the manufacture or design of the device which could have contributed to the reported event is the controller or foot control which were not returned for evaluation.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: 10681253
• Report Number: 3006524618-2020-00883
• Device Sequence Number: 14193460
• Product Code: GEI
• UDI-Device Identifier: 00817470005240
• UDI-Public: 00817470005240
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2023
• Device Model Number: EICA6895-01
• Device Catalogue Number: EICA6895-01
• Device Lot Number: 2054763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention