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

Catalog Number	EICA8875-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tonsillectomy, the device began smoking, the device was reported as much warmer than normal during use by the surgeon.There were no sparking or arcing during the case.A backup device was available to complete the procedure successfully, delay and patient injuries were not reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because 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 and a root cause could not be determined with confidence.If the device associated with this event is returned at a future date, this evaluation will be reopened for investigation.The procise ez view coblator ii wand will create steam when sufficient suction is not used and give the user the perception that it is smoking.This occurs when the wand is burning off the residual fluid on the distal tip.Any lack of suction will also enhance and promote a more visual effect.The instruction for use contains warnings and precautionary statements regarding maintaining proper suction flow and potential device failure if not adhered to.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: 8353878
• Report Number: 3006524618-2019-00104
• Device Sequence Number: 1915050
• Product Code: GEI
• UDI-Device Identifier: 00817470004335
• UDI-Public: 00817470004335
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 08/24/2021
• Device Catalogue Number: EICA8875-01
• Device Lot Number: 2019073
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1