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

Catalog Number	ACH4041-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during a microablation plantar fascia procedure, a piece of the tip of the wand broke off.Just a piece of the small tip wasn't able to be retrieved from the foot.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
The product was not returned for evaluation and had been intended to be used for treatment.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Potential factors unrelated to the manufacturing or design of the device which could have contributed to the reported event includes: 1.Failure to follow instructions may lead to improper functioning of the device.2.Check the wand tip periodically to ensure the electrode is intact and the wand is functioning as intended.If the electrode is not intact, discontinue use and check the tissue by appropriate means.3.Resistance, upon wand insertion into the target tissue, may be indicative of an inadequate incision site (i.E.Size).This resistance may damage the wand tip resulting in possible injury to the patient or user.There are no indications to suggest 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: 9126465
• Report Number: 3006524618-2019-00488
• Device Sequence Number: 16848832
• Product Code: GEI
• UDI-Device Identifier: 00817470003574
• UDI-Public: 00817470003574
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2019

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: 05/30/2022
• Device Catalogue Number: ACH4041-01
• Device Lot Number: 2035056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1