MAUDE Adverse Event Report: ARTHROCARE CORPORATION FA QUANTUM 2 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 28168

Device Problem Failure to Conduct (1114)

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

Event Date 08/19/2023

Event Type  malfunction  

Event Description

It was reported that during an unspecified procedure, the quantum 2 controller presented an "e8 wand error", despite of using a new wand in the brand-new machine.A delay greater than 30 min was reported, and the procedure was finished with a competitor device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Manufacturer Narrative

H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the manufacturing specifications found that the operator should reject any unit that fails any of the inspection points of the procedure, fill a reject label and send the controller to troubleshooting for its repair.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: FA QUANTUM 2 CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17959798
• MDR Text Key: 326932530
• Report Number: 3006524618-2023-00394
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001891
• UDI-Public: 00817470001891
• Combination Product (y/n): N
• Reporter Country Code: NP
• PMA/PMN Number: K082666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 28168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1