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

Catalog Number	EICA6895-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during surgery that the iv tubing got smashed during packaging, they were crimped together when taken out of the package.The procedure was completed with manual instruments, there was no back up device available.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection under magnification shows minimal electrode wear with tissue and discoloration present on the electrodes.There are no discrepancies visually observed with the saline/suction lines.There are no manufacturing abnormalities visually observed with the returned device.The wand was connected to a compatible controller and activated in a beaker of saline solution at the default and max settings and performed as intended.The saline line was connected to a saline bag at approximately 3 feet and saline flowed through-out the line to the tip of the device as intended.The suction line was tested and performed as intended.The complaint could not be verified and the root cause for this event could not be determined with confidence.There are no discrepancies with the devices suction or saline line as the lines are manufactured ¿smashed¿ together near the handle of the device.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
Initial information stated that procedure was completed with manual instruments and no backup device was available.Additional information was received from reporter stating that procedure was successfully finished with an equivalent technique (manual instruments), there was no patient impact and no delay, therefore, this information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The reassessment 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.

• 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: 8198972
• Report Number: 3006524618-2018-00673
• Device Sequence Number: 16192190
• 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,Followup
• Report Date (Section B): 05/06/2019

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: 06/08/2021
• Device Catalogue Number: EICA6895-01
• Device Lot Number: 2015409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2018
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/30/2019; 04/29/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/31/2019; 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1