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

Catalog Number	EICA8875-01
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the device had electrical sparks.There was a backup device available.No delay or patient injury was reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There are several factors that could contribute to the reported complaint such as maintaining the recommended suction and/or ensuring saline delivery is only intended to facilitate the formation of plasma.When the recommended suction pressure is not used, this will give the user the perception that the device is ¿sparking¿.This occurs when the wand is burning off the residual fluid on the distal tip.The instruction for use contains other warnings and precautionary statements to adhere during activation 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.

• Brand Name: PROCISE EZ VIEW COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8794564
• Report Number: 3006524618-2019-00337
• Device Sequence Number: 1707897
• Product Code: GEI
• UDI-Device Identifier: 00817470004335
• UDI-Public: 00817470004335
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 08/21/2019

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: 01/03/2022
• Device Catalogue Number: EICA8875-01
• Device Lot Number: 2026026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1