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

Catalog Number 28168

Device Problem Protective Measures Problem (3015)

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

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that there was f4 error on the screen of the fa quantum 2 controller.It is unknown if there were delays and when did the malfunction happened.A back up device was used to complete the procedure.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 not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.Visual inspection of the customer provided picture shows a quantum unit with a f4 fault displayed on the screen.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.The complaint was confirmed and the root cause is associated with a 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.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: the reported unit was received for evaluation.It was determined the device contributed to the reported event.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 found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Visual inspection of the customer provided picture shows a quantum unit with a f4 fault displayed on the screen.Visual inspection of the rf12000, q2 controller s/n is not readeable, the original label is exchanged; the warranty seal is completely removed; the manufacturing date of the controller is not readeable.No visible manufacturing anomalies were found; after power up the quantum2 controller and connnecting concomitant devices the unit show no abnormalities and worked as intended; no hardware failure f4 as reported was found; the unit properly perfomed as specified and produced the output voltages [vmrs] on coag/ablate as intended on all setting points; but during the temperatue reading test the display show errors up to total failure - showing no information in the display; the complaint was confirmed and the root cause is associated with design.Factors, which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.A corrective action has been initiated to mitigate future recurrence of similar events.

• Brand Name: FA QUANTUM 2 CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11095367
• MDR Text Key: 224392649
• Report Number: 3006524618-2020-01164
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 06/20/2022
• Supplement Dates FDA Received: 01/31/2021; 06/21/2022
• 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: Unknown
• Patient Sequence Number: 1