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 Unspecified Infection (1930)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: shao juan.(2006).Clinical observation of radiofrequency ablation in the treatment of obstructive sleep apnea hypopnea syndrome.Traffic medicine, 20(3), 328-329.

Event Description

It was reported that on literature review clinical observation of radiofrequency ablation for obstructive sleep apnea hypopnea syndrome, 3 patients had a local wound infection after a radiofrequency ablation procedure using a disposable reflex 55 coblation wand.The events were treated with antiinflammatory treatment which cause an improvement.Patients outcome is unknown.No further information is available.

Manufacturer Narrative

H10: 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.Without supporting clinical/medical documents, a thorough investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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 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: 13954551
• MDR Text Key: 288276223
• Report Number: 3006524618-2022-00123
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention