MAUDE Adverse Event Report: ARTHROCARE CORP. FA RF8000E,240V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number ED13546-02

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/20/2018

Event Type  malfunction  

Event Description

It was reported that the plasma is not forming on the wands.When checked with new wands, the issue persists.There was a postponed delay of more than 60 min.No patient injury reported.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: a power surge to the subject controller, using an improper power cord or improper extension cord, or a loose power connection, failure of an electronic component inside the subject controller.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: FA RF8000E,240V
• 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: 7480009
• MDR Text Key: 107476495
• Report Number: 3006524618-2018-00214
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ED13546-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/02/2018
• 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