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	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient initials (b)(6).
Event or Problem Description
It was reported that the wand was lacking of suction and when they tried to remove it the wand started smoking on the operating field.Procedure was completed with a back-up device.No patient injury reported.
Additional Manufacturer Narrative
The device, intended for use 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 discoloration present on the tip from activation.There are no manufacturing discrepancies visually observed with the returned device.The wand was tested using a compatible controller and activated in a beaker of saline solution at default and maximum settings in which the ablation and coagulation 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.As the saline and suction lines were tested, the ablate function was activated and plasma was observed as intended.At no time during functional evaluation there was smoke emitted which would conclude that there is no electrical disturbance related to the wand.Functional evaluation revealed that the returned device performed as intended; therefore, the complaint could not be verified and the root cause could not be determined with confidence.The procise max 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.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: 7515503
• Report Number: 3006524618-2018-00249
• Device Sequence Number: 19123805
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: (01)00817470003888(17)201006(10)2007107
• Combination Product (Y/N): N
• 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): 06/22/2018

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: 10/06/2020
• Device Model Number: EICA8898-01
• Device Catalogue Number: EDEICA8898-01
• Device Lot Number: 2007107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/20/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR