MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT MEGAVAC 90; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	ASCA5001-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device did not work, when it was connected it displayed an error e7.There was a significant delay greater than 30 minutes and a backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
The device was returned as an mdr for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows minimal electrode wear with contamination/discoloration on screen and scratch/scuff marks on the spacer and cap.There are no manufacturing abnormalities visually observed with the returned device.The device was connected to a compatible quantum2 controller and did not work; registered an e-7 error message.The e-7 error was bypassed and was activated in saline solution at the default and max settings on the controller and performed as intended.The complaint was verified as an e-7 error was experienced.The root cause could not be determined with confidence.Factors that could have led to the e-7 error includes: the rf controller may have been turned off following connection of the wand or source power may have been interrupted prior to wand activation.Other factors that could contribute to an e-7 error include disconnecting the wand from the controller after power has been turned on, previous use or incorrect power cycling of the controller.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT MEGAVAC 90
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7534659
• Report Number: 3006524618-2018-00266
• Device Sequence Number: 11188607
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: (01)00817470001761(17)201109(10)2007988
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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
• Operator of Device: Health Professional
• Device Model Number: ASCA5001-01
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2007988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1