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

Catalog Number 13546-01

Device Problems Power Conditioning Problem (1474); Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 04/18/2018

Event Type  Injury  

Event Description

It was reported that the generator was not producing enough power.Patient came back with post tonsil bleeding.

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.Warranty seal is broken.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.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
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7511050
• MDR Text Key: 108157490
• Report Number: 3006524618-2018-00240
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 13546-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 06/22/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other