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	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during three cases the coblator does not have the required efficiency for a turbinate reduction.However, the turbinate tissue is still and not reduce as what it can perform normally.No back up device was available.
Additional Manufacturer Narrative
The returned system and the reported incident as the system performed to specification.The visual inspection shows no damages, scratches and no dents.The coblator ii unit is visually not compromised.The warranty void is untouched and in its original condition.There are no manufacturing abnormalities visually observed with the returned unit.The complaint was not verified and the root cause root cause of the complaint could probably be determined with factors unrelated to the design and manufacture of the unit which could have contributed to the complaint event are outlined in the technical specification provided with the device associated with set up, used accessories and use of the device.There were no indications that would suggest that the system 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: 8391892
• Report Number: 3006524618-2019-00127
• Device Sequence Number: 19313395
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 04/02/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1