MAUDE Adverse Event Report: ARTHROCARE CORP. ELIMINATOR ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC1345-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the pedal was operated to start being used, it did not work.We completed the procedure with another device from the other company.No patient injuries were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.Visual inspection under magnification shows no wear on the electrodes with no signs of activation.There are no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible controller and activated in saline solution at the default and max settings on the controller and performed as intended.The complaint could not be verified as the device performed as intended and the root cause could not be determined with confidence as several factors could have contributed to the reported event such as: not having sufficient saline in order to facilitate the formation of plasma, or the wand or foot control connector may have become disconnected from the controller display.Factors unrelated to the manufacture or design of the device which could have contributed to the reported event is the controller or foot control which were not returned for evaluation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ELIMINATOR ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7073525
• Report Number: 3006524618-2017-00382
• Device Sequence Number: 19195037
• Product Code: GEI
• UDI-Device Identifier: 00817470001860
• UDI-Public: (01)00817470001860(17)200430(10)1194620
• Combination Product (Y/N): N
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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 Model Number: AC1345-01
• Device Catalogue Number: AC1345-01
• Device Lot Number: 1194620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1