MAUDE Adverse Event Report: ARTHROCARE CORP. TURBINATOR COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EIC6895-01

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an inferior turbinoplasty, the turbinator coblator ii was clogged despite flushing it with saline.When the surgeon depressed on the ablate pedal no orange spark was formed when the wand was placed in saline.The procedure was completed with a delay greater than 30 minutes, using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.The device was plugged into the controller and registered settings (7,3).The wand was able to generate plasma as intended.No clogging observed during functional testing.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.Internal complaint reference: (b)(4).

• Brand Name: TURBINATOR COBLATOR II
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11362881
• MDR Text Key: 233055037
• Report Number: 3006524618-2021-00231
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000382
• UDI-Public: 00817470000382
• Combination Product (y/n): N
• PMA/PMN Number: K202006
• 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: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2022
• Device Model Number: EIC6895-01
• Device Catalogue Number: EIC6895-01
• Device Lot Number: 2029648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1