MAUDE Adverse Event Report: ARTHROCARE CORP. UNKN COBLATOR II SURGERY SYSTEM AND WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 09/29/2012

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Literature: submucosal lingualplasty for adult obstructive sleep apnea.Doi: 10.1177/0194599812461750.

Event Description

It was reported that on literature review, "submucosal lingualplasty for adult obstructive sleep apnea", after a submucosal lingualplasty with an evac 70 wand was used, five patients had a long-term altered swallowing sensation (6 months post-operative).The patients' outcome is unknown.No further information is available.

Manufacturer Narrative

H10 h6 the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.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.It has been communicated that no further information can be provided for this case.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all of the attached images.Therefore, no further interpretation of the attached images are required.No further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event 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.

• Brand Name: UNKN COBLATOR II SURGERY SYSTEM AND WAND
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 12253173
• MDR Text Key: 264311724
• Report Number: 3006524618-2021-00795
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other