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

Catalog Number	EC8001-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during surgery the irrigation channel was not working properly due to which poor plasma, weak cutting with charring and smoke was seen.There was no back-up available to complete the procedure.It is unknown if there was a delay.
Additional Manufacturer Narrative
The returned unit, intended for use in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.Visual inspection shows no visible damages and no manufacturing abnormalities.The warranty seal is untouched and in its original condition.During functional evaluation, the controller was powered up and the display shows not abnormalities; after plug in a know good test wand a known good foot pedal device the unit was activated and immediately indicates an alarm associated with the red attention led; no output could be measured; there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during surgery the irrigation channel was not working properly due to which poor plasma, weak cutting with charring and smoke was seen.There was no back-up available to complete the procedure, there was a delay of more than one hour and the procedure was postponed.

• 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: 8609728
• Report Number: 3006524618-2019-00227
• Device Sequence Number: 19590538
• 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): 07/12/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1