MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Adhesion(s) (1695)

Event Date 12/01/2012

Event Type  Injury  

Event Description

It was reported that on literature review effect of inferior turbinate low-temperature plasma radiofrequency treatment in chronic rhinitis and allergic rhinitis, 4 patients had complications after a low-temperature plasma radiofrequency procedure using a coblator ii surgery system with reflex ultra 45 wand.2 patients had nasal adhesions 2 weeks after the procedure, which were relieved after separation under surface anesthesia, 2 other patients continue having hypertrophy of the inferior turbinate after the procedure, which required a revision surgery and the nasal obstruction improved 2 months later.No further information is available.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Paper: effect of inferior turbinate low-temperature plasma radiofrequency treatment in chronic rhinitis and allergic rhinitis.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H6: inspection and functional testing could not be performed.A complaint history review found similar reported events.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Per case details, per literature review, ¿effect of inferior turbinate low-temperature plasma radiofrequency treatment in chronic rhinitis and allergic rhinitis,¿ 4 patients had complications after a low-temperature plasma radiofrequency procedure using a coblator ii surgery system with reflex ultra 45 wand.2 patients had nasal adhesions 2 weeks after the procedure, which were relieved after separation under surface anesthesia, 2 other patients continue having hypertrophy of the inferior turbinate after the procedure, which required a revision surgery and the nasal obstruction improved 2 months later.No further information is available.Smith and nephew has not received the requested patient specific documentation, the explanted device, and/or adequate materials to fully evaluate the root cause of the complaint.Patient impact beyond that which was reported could not be determined.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed, and the root cause could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13995676
• MDR Text Key: 288593536
• Report Number: 3006524618-2022-00175
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other