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

Catalog Number 28168

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2020

Event Type  Injury  

Event Description

It was reported that before case, the controller had a f4 error code when the power was turned on.No patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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.Visual inspection observed no issues.Functional evaluation revealed the unit presented a f4 fault on power up, most settings could not be tested.The unit was opened and found a display cable not fully seated.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 related failures.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.No containment or corrective actions are recommended at this time.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• Brand Name: QUANTUM 2 CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10125098
• MDR Text Key: 194204158
• Report Number: 3006524618-2020-00338
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K082666
• 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: 07/03/2020

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
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1