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

Model Number ACH4041-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/24/2018

Event Type  malfunction  

Event Description

It was reported that the wand did not perform any function.No backup device available.

Event Description

It was reported that the wand did not perform any function.Case was completed, using a different method and non-smith & nephew device.No backup device was available.No delay or patient injuries were reported.

Manufacturer Narrative

Event description updated.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.The instruction for use (¿ifu¿) outlines instructions for proper set up prior to activation of the device.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Device evaluated by the manufacturer.Evaluation codes updated.

• Brand Name: TOPAZ EZ IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7528508
• MDR Text Key: 108938113
• Report Number: 3006524618-2018-00260
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: (01)00817470003574(17)190501(10)1142461
• Combination Product (y/n): N
• PMA/PMN Number: K140521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: ACH4041-01
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 1142461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/19/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1