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

Model Number	EICA8898-01
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced severe burns around the lip and mouth area where the mouth gag was placed to perform the procedure.There was no delay 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.Factors that could contribute to the reported event includes: activating the device prior to contact with targeted tissue, failure to maintain suction and direct fluid outflow away from the operative field, 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 or user and result in burns.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 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: 7651696
• Report Number: 3006524618-2018-00351
• Device Sequence Number: 1433113
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: (01)00817470003888(17)200923(10)2006877
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: EICA8898-01
• Device Catalogue Number: EICA8898-01
• Device Lot Number: 2006877
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other