MAUDE Adverse Event Report: ARTHROCARE CORPORATION UNKNOWN COBLATION ENT DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EC8000-01

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

Patient Problems Adhesion(s) (1695); Stenosis (2263)

Event Date 01/01/2009

Event Type  Injury  

Event Description

It was reported that on literature review application of plasma-mediated cold ablation in otorhinolaryngology, 1 patient had pharyngostenosis due to adhesions after a tonsillectomy procedure using a coblator ii controller device.A pharyngoplasty was recommended but it is unknown if it was performed.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review and complaint history review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The data presented in the aged article did not provide insight or relevance to current clinical outcomes for the product/device.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.Correction in h6 (health effect - clinical code).

• Brand Name: UNKNOWN COBLATION ENT DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15843606
• MDR Text Key: 304100458
• Report Number: 3006524618-2022-00487
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001976
• UDI-Public: 00817470001976
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K082666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EC8000-01
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other