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

Model Number	EICA8898-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that wand was sparking outside of the patient.Device did not overheat.No patient or user injury was reported.A backup device was available to complete the procedure with no major delay.
Additional Manufacturer Narrative
There was no relationship found between the returned device and the reported incident.Visual inspection under magnification shows minimal electrode wear.There are no manufacturing abnormalities visually observed with the returned device.The wand was activated in a beaker of saline using a compatible controller and plasma was only present on the electrodes.Plasma was created (not sparking) on the return electrode where conductive media is present producing a glow which is normal.Depending on the angle of the wand and the area of contact from the conductive media is where the glow is present.Steam ("smoke") was then created by removing the wand from the saline solution, turning off the suction and activating.This is normal when the device is not activated in sufficient conductive media and proper suction is not used.At no time during activation, the tip exhibited ¿sparking¿; therefore, functional testing concluded that there is no electrical disturbance related to the wand.The customer¿s complaint could not be verified and the root cause could not be determined with confidence as the returned device performed as intended during functional evaluation.It is possible that the tip of the wand made contact with a metal object such as a mouth guard that could cause this type of reported failure.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 MAX COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7349613
• Report Number: 3006524618-2018-00133
• Device Sequence Number: 709137
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: (01)00817470003888(17)200912(10)2006845
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 09/12/2020
• Device Model Number: EICA8898-01
• Device Catalogue Number: EICA8898-01
• Device Lot Number: 2006845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1