MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATOR II CONTROLLER (240V); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-02

Device Problem Output below Specifications (3004)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that, during an ent procedure, the "coblator ii controller (240v)" showed ineffective plasma formation resulting in a lackluster tissue ablation.The procedure was successfully completed without significant delay by a change in the surgical technique.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records showed there were 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 ifu 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 do not reuse plasma wand¿ devices that have been designed for single use to avoid failure or unanticipated performance.Select the wand type most appropriate for the procedure.The controller will preset nominal and maximum coblate and coagulation voltages for each wand style to ensure a safe and effective operation.In order to adjust the voltage setting, the wand must be connected to the controller.A visual inspection observed a damaged lid, bezel, and overlay.A functional evaluation revealed no issues.The unit was opened and found rust on the floor of the unit.The failure of no output was not verified, and the failure of rust was verified.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.

• Brand Name: COBLATOR II CONTROLLER (240V)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10961884
• MDR Text Key: 220158760
• Report Number: 3006524618-2020-01065
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 13546-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention