MAUDE Adverse Event Report: ARTHROCARE CORP. FA COBLATOR II CONTROLLER (120V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-01

Device Problem Failure to Power Up (1476)

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

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the controller was not supplying power to the flow control unit before a tonsillectomy and adenoidectomy.The procedure was completed manually by the nurse, she held the saline bag overhead and opened and closed the valve manually to start and stop saline flow.No delays 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

Internal complaint reference case-(b)(4) h10 h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Review of the product instructions for use found adequate warnings and precautions to prevent damage to the device during use.A review of risk management files found that the reported failure was documented appropriately.Please refer to the instructions for use for recommendations on use of other than fuse replacement, the controller has no user-serviceable parts.It is designed to provide consistent output levels and is calibrated by clock crystals, voltage references, and fixed resistors.There are no internal adjustments in the instrument and, due to the integrated calibration methods, no annual maintenance check is required.There is no software incorporated in the coblator¿ ii (rf8000e) system controller.If any component malfunctions, call customer service for a return authorization.A service manual is available upon request.Smith & nephew reusable flow control valve equipment is subject to various factors that can affect functional life which include frequency of use, method and duration of use, as well as post-operative methods and handling.Proper maintenance of your equipment is essential to achieve optimal performance over time.Symptoms of lifetime failures include but are not limited to the following: connection problems with ancillary equipment nicked, cut, or frayed cord connected indicator light does not illuminate missing/damaged operation controls wear smith & nephew recommends returning the device for service if any of the above symptoms cannot be resolved or as needed to maintain optimal performance.Visual inspection observed no issues.Functional evaluation revealed the flow valve does not function when activated.The unit was opened and found no issues.The complaint was confirmed and the root cause is associated with an electrical component failure.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.

• Brand Name: FA COBLATOR II CONTROLLER (120V)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11066125
• MDR Text Key: 223424591
• Report Number: 3006524618-2020-01133
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13546-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention