MAUDE Adverse Event Report: ARTHROCARE CORPORATION 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	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that the device does not work and causes short circuit.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.We cannot determine if there is a relationship between the device and the incident because the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence as more than likely an e-7 error was experienced which will cause the device to not work "short circuit".Factors that could have led to an e-7 error includes: the rf controller may have been turned off following connection of the wand or source power may have been interrupted.The ambient megavac 90 wand incorporates a single-use feature which is designed to prevent reuse of the wand.There are other factors that could contribute to an e-7 error such as disconnecting the wand from the controller after power has been turned on, previous use or incorrect power cycling of the controller.Also, a reprocessed wand used by the customer will exhibit an e-7 error.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that the device does not work and causes short circuit.It is unknown when did the event occurred, if a back up device was available or if a delay was caused by the device malfunction, but no patient injuries were reported.
Additional Manufacturer Narrative
The 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 no wear on the electrodes with no manufacturing abnormalities visually observed with the returned wand.The wand was connected to a compatible controller and registered an e-7 error.The error was by-passed and was activated in saline solution at the default and max settings on the controller and performed as intended.The suction line was tested and performed as intended.The complaint was verified, but the root cause could not be determined with confidence as more than likely an e-7 error was experienced which will cause the device to not work "short circuit".Factors that could have led to an e-7 error includes: the rf controller may have been turned off following connection of the wand or source power may have been interrupted.The ambient megavac 90 wand incorporates a single-use feature which is designed to prevent reuse of the wand.There are other factors that could contribute to an e-7 error such as disconnecting the wand from the controller after power has been turned on, previous use or incorrect power cycling of the controller.Also, a reprocessed wand used by the customer will exhibit an e-7 error.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 CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7805403
• Report Number: 3006524618-2018-00428
• Device Sequence Number: 16570792
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: (01)00817470001761(17)200907(10)2006096
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2019

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: 09/07/2020
• Device Model Number: ASCA5001-01
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2006096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 02/25/2019
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/15/2018; 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1