MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATOR II CONTROLLER; OPERATOR CONSOLE, DIATHERMY UNIT

Catalog Number ED13546-59S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn(s) (1757)

Event Date 08/04/2015

Event Type  Injury  

Event Description

It was reported that following a tonsillectomy procedure using a coblator ii controller with an evac 70 xtra hp wand, it was noticed that the patient had sustained a small burn on the tongue.No further details were provided regarding the severity of the burn or any treatment administered, however no additional patient complications have been reported.

Manufacturer Narrative

The controller, foot control and wand related to this complaint event were returned for evaluation.Visual and functional inspection was done and all devices functioned as intended.The customer's complaint could not be verified and a root cause could not be determined in association with the subject system due to the controller, foot control assembly, and wand functioning as intended when tested.Potential factors unrelated to the manufacture or design of the device which could have contributed to the reported event include: 1.Insufficient saline flow to the surgical site during the procedure.2.Surgical technique of the user.3.An issue with one of the concomitant devices.There were no indications during manufacturing record review that would suggest that the devices did not meet product specifications upon release into distribution.

• Brand Name: COBLATOR II CONTROLLER
• Type of Device: OPERATOR CONSOLE, DIATHERMY UNIT
• 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: jim gonzales ; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 5051671
• MDR Text Key: 24886930
• Report Number: 3006524618-2015-00505
• Device Sequence Number: 1
• Product Code: BWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: ED13546-59S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other