MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATOR II CONTROLLER 240V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EC8001-01
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the device had a crackling noise with smoke coming out of the controller, the it stopped working.It is unknown when did the event occurred, if a back up device was available to complete the procedure or if a delay was caused by the device malfunction, but no patient injuries were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: COBLATOR II CONTROLLER 240V
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8732143
• Report Number: 3006524618-2019-00304
• Device Sequence Number: 16762229
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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 Catalogue Number: EC8001-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1