MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN COBLATION SPORTSMED DEV; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKN04300201

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

Patient Problem Adhesion(s) (1695)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that on literature review clinical curative effects of low-temperature plasma inferior nasal concha radiofrequency ablation under nasal endoscopy in treatment of chronic rhinosinusitis, 1 patient had nasal adhesions after a of low-temperature plasma inferior nasal concha radiofrequency ablation under nasal endoscopy procedure using a coblator ii surgery system.It is unknown how was the event treated.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).Article citation: salzano f, mora r, dellepiane m, et al.Radiofrequency, high-frequency, and electrocautery treatments vs partial inferior turbinotomy: microscopic and macroscopic effects on nasal mucosa.Arch otolaryngol head neck surg.2009;135(8):752¿758.Doi:10.1001/archoto.2009.87.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record, complaint history, device labeling/ifu, risk management and capa, nc, pra/hhe 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.No relevant supporting clinical information could be provided to assist with this clinical investigation.Per case complaint details, no further information is available.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.There was no relationship found between the device and the reported event.The complaint was not confirmed.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 COBLATION SPORTSMED DEV
• 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: 13995116
• MDR Text Key: 288485893
• Report Number: 3006524618-2022-00167
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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: UNKN04300201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention