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	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was no relationship between the returned device and the reported incident.Visual inspection under magnification shows no electrode wear with minor discoloration from activation.There are no manufacturing abnormalities observed with the returned device.The wand was connected to a compatible controller and registered an e-7 error.The error was by-passed and the wand was activated in saline solution at the default and max settings on the controller and performed as intended.At no time during functional testing the wand continued to activate while the foot control was not pressed.The suction line performed as intended.The complaint could not be verified as the returned device performed as intended.The root cause could not be determined with confidence as there are several factors unrelated to the manufacture or design of the device which could have contributed to the reported event including: there could be a discrepancy with the foot control receiver and/or cable which were not returned for evaluation.It is possible that excessive tensile stress applied to the cable could have partially broken one or more signal wires causing an intermittent connection.More than one wireless foot control assembly in the general vicinity could have the same frequency; therefore, inadvertently allowing activation.
Event or Problem Description
It was reported that the device got stuck on the on position.No patient injury was reported.The device continuously run.

• 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: 7843627
• Report Number: 3006524618-2018-00451
• Device Sequence Number: 1567249
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: (01)00817470001761(17)210223(10)2010927
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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 Expiration Date: 02/23/2021
• Device Model Number: ASCA5001-01
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2010927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1