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

Catalog Number UNKN04300101

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

Patient Problem Abscess (1690)

Event Date 01/06/2009

Event Type  Injury  

Event Description

It was reported that on literature review "the treatment effect for obstructive sleep apnea-hypopnea syndrome with radio frequency ablation surgery", one patients had a abscess formation at the lingual root after a radiofrequency ablation procedure using a reflex 45, reflex 55 wand and a coblator ii surgery system.The event was resolved with antibiotics and also by making another incision for drainage.Patient outcome is unknown.No further information is available.

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: mu s, sun c, song j, liu l, qu y, liu l, cui l, zhao l, yin w, wang l.[effect and indications of radiofrequency ablation for the treatment of obstructive sleep apnea-hypopnea syndrome].Lin chung er bi yan hou tou jing wai ke za zhi.2007 nov;21(21):981-4.Chinese.Pmid: 18309654.

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.The article provided was not presented in a readable format.Per case details no further information is available, and no sample will be returned.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: 13995446
• MDR Text Key: 288494289
• Report Number: 3006524618-2022-00163
• 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: 08/21/2022

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: UNKN04300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• 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