MAUDE Adverse Event Report: ARTHROCARE CORP. REFLEX ULTRA 45 COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EIC4845-01
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a turbinate reduction procedure, the reflex ultra wand did not coblate as it should, it actually burned rather than form a plasma.There was no delay.It is unknown if the procedure was successfully completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: REFLEX ULTRA 45 COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10835290
• Report Number: 3006524618-2020-00989
• Device Sequence Number: 17146801
• Product Code: GEI
• UDI-Device Identifier: 00817470004212
• UDI-Public: 00817470004212
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

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: 12/18/2022
• Device Model Number: EIC4845-01
• Device Catalogue Number: EIC4845-01
• Device Lot Number: 2046662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1