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

Model Number	EICA4835-01
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a turbinate reduction the reflex ultra coblator default was 0 and 0 instead 4 and 2.The wand would not ablate or create plasma.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during manufacturing process related to the reported event.A complaint history review found no related failures; this failure mode will be trended to assess for any necessary corrective actions.Visual inspection of the device revealed minimal erosion of the electrode tip.The device was connected to a known good controller, which revealed that the wand's mechanical use limiting system (muls) was activated, preventing the output of the wand.The wand was then bypassed, which revealed that the device's ablate and coagulate functions performed as intended.The complaint was verified as the device's muls was activated.The root cause was determined to be due to reuse of a single device.Factors, which may have contributed to the reported complaint include: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: REFLEX ULTRA PTR COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10292670
• Report Number: 3006524618-2020-00511
• Device Sequence Number: 3162474
• Product Code: GEI
• UDI-Device Identifier: 00817470003871
• UDI-Public: 00817470003871
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 11/14/2021
• Device Model Number: EICA4835-01
• Device Catalogue Number: EICA4835-01
• Device Lot Number: 2043706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1