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	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the wand was put under no more stress than normal and part of the electrode popped off.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows extensive electrode wear and scratch/scuff marks on the spacer and cap.The screen is completely detached and returned with the device.A part of the spacer is broken-off.The insulation around the shaft is scratched but not compromised.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.The suction line was tested and performed as intended.

• 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: 7492780
• Report Number: 3006524618-2018-00226
• Device Sequence Number: 16425284
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: (01)00817470001761(17)200930(10)2006850
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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 Expiration Date: 09/30/2020
• Device Model Number: ASCA5001-01
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2006850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1