MAUDE Adverse Event Report: ARTHROCARE CORP. FA RF8000E,120V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 13546-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2018

Event Type  malfunction  

Event Description

It was reported that device is not working properly.No backup device was readily available, a competitive cautery pencil was used to complete the procedure with no delay or patient injuries.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.There was a relationship found between the reported incident and the returned device.Visual inspection of the returned controller found that the foot pedal connector port was damaged.Internal inspection found no issues inside the controller.Also warranty seal was broken.Functional evaluation revealed that the controller did not function as intended.All ablation and coagulation output voltages were not able to be tested due to the coag not responding.The complaint was verified and the root cause was determined to be associated with an electrical component failure.Factors which can lead to internal component damage includes: (1) there may have been a loose foot control assembly or wand connection to the controller which could have caused non-functionality or (2) an issue with the other concomitant devices.

• Brand Name: FA RF8000E,120V
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7528484
• MDR Text Key: 108943961
• Report Number: 3006524618-2018-00258
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

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: 13546-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/19/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1