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 Electric Shock (2554)

Event Date 03/13/2018

Event Type  malfunction  

Event Description

It was reported by customer that patient experienced electrical shock symptoms during the procedure, since device was not working properly.

Manufacturer Narrative

Investigation was updated.The device, intended for use in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.Visual inspection of the returned controller only had minor scratches.Functional evaluation revealed that the controller functioned as intended according to the reported event.All ablation and coagulation output voltages fell within specified ranges.The complaint was not verified and the root cause was unable to be determined since the device functioned as intended.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.There was no relationship found between the reported incident and the returned device.Visual inspection of the returned controller only had minor scratches.Functional evaluation revealed that the controller functioned as intended according to the reported event.All ablation and coagulation output voltages fell within specified ranges.The complaint was not verified and the root cause was unable to be determined since the device functioned as intended.Potential factors unrelated to the manufacturing or design of the device that could have contributed to the reported event includes: (1) there could have been a power surge to the controller which could have caused the controller not to work or (2) there may have been a loose power connection or interference between other devices.A review of the manufacturing records found that the device did meet manufacturing specifications at the time of release into distribution.

• 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: 7535265
• MDR Text Key: 109107821
• Report Number: 3006524618-2018-00267
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2018

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: 05/07/2018
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 05/17/2018; 06/10/2018
• Supplement Dates FDA Received: 05/25/2018; 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1