MAUDE Adverse Event Report: ARTHROCARE CORP. TOPAZ EZ IFS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ACH4041-01
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wand did not perform any function.There was no backup device available.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There is no relationship between the device and the reported event.Visual evaluation under magnification shows no electrode wear with no signs of activation.There are no manufacturing abnormalities visually observed with the returned wand.The wand was first connected to a compatible werewolf controller and registered multi-use fuse had expired.The wand was then connected to a compatible quantum 2 controller and registered an e-7 error.The error was by-passed and the wand was activated in saline solution at 0.5 seconds per activation and performed as intended.The saline line was tested and performed as intended.The complaint could not be verified as the device performed as intended during functional evaluation.The root cause could not be determined with confidence as several factors could have contributed to the customer¿s complaint.It is possible that sufficient saline ¿conductive media¿ was not used in order to facilitate the formation of plasma.Also, factors unrelated to the manufacture or design of the device which could have contributed to the reported event is the controller, foot control and/or accessories 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: TOPAZ EZ IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7528505
• Report Number: 3006524618-2018-00259
• Device Sequence Number: 1512312
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: (01)00817470003574(17)190831(10)1161473
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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 Expiration Date: 08/31/2019
• Device Model Number: ACH4041-01
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 1161473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/19/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1