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	06/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the device presented heating.Occurred during procedure.No delay was reported, a back-up was not available.
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 as the device functionally performed as intended.Visual evaluation under magnification shows moderate electrode wear with dried tissue and blood present on the electrodes.Further visual evaluation with an unaided eye found no manufacturing abnormalities with the returned device.The wand was connected to a compatible controller and activated in saline solution at the default and max settings in which the ablate and coagulation performed as intended.The suction and saline lines were tested and performed as intended.During functional evaluation there was no signs of abnormal heating/steam.The complaint could not be verified as the returned device functionally performed as intended.It is feasible that if the exposed section of the shaft near the distal tip comes into contact with untargeted tissue, it could cause blanching.Other factors that could contribute to the reported event includes: failure to maintain suction could create steam which may cause thermal injury, withdrawing the wand while power is being applied or contact with metal surgical instruments (such as a mouth guard) may pass current to the patient and result in burns.Steam can be present when insufficient suction is 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.The instructions for use provided with the device contains warnings and precautionary measures related to proper use of the device.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications.

• 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: 7626250
• Report Number: 3006524618-2018-00335
• Device Sequence Number: 2292514
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: (01)00817470003888(17)210202(10)2009797
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2018

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: 02/02/2021
• Device Model Number: EICA8898-01
• Device Catalogue Number: EICA8898-01
• Device Lot Number: 2009797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 08/17/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 06/25/2018; 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR