MAUDE Adverse Event Report: ARTHROCARE CORP. PARAGON T2 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC5531-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a wrist scope, the surgeon was using the rf wand but there were bluish chips seen.The procedure was completed with the same device.No delay or patient injury reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.If the device associated with this event is returned at a future date, this evaluation will be reopened for investigation.It is possible that the device either came into contact with a hard (metallic) object or was continuously rubbed against another object which will cause the temperature indicator to become detached or smudged.
Event or Problem Description
It was reported that during a wrist scope, the surgeon was using the rf wand but there were bluish chips seen, these material were removed from patient.The procedure was completed with the same device.No delay or patient injury reported.

• Brand Name: PARAGON T2 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8446418
• Report Number: 3006524618-2019-00152
• Device Sequence Number: 19580596
• Product Code: GEI
• UDI-Device Identifier: 00817470003512
• UDI-Public: 00817470003512
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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: 01/26/2021
• Device Catalogue Number: AC5531-01
• Device Lot Number: 2010444
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1