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

Catalog Number 28168

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that, during set up for a hip surgery, the "quantum controller" was not getting power.It is unknown if a back-up device was available or if there was a delay in the surgical procedure.No patient injuries 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

H10 h3,h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.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 evaluation will be reopened for investigation.There are no indications to suggest that the device/product did not meet specifications upon release into distribution.

• 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
• MDR Report Key: 10607987
• MDR Text Key: 209245531
• Report Number: 3006524618-2020-00840
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1