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

Catalog Number	ASCA5001-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was heating up.The shoulder procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Event or Problem Description
It was reported that during a shoulder procedure the device was heating up.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Additional information.The device, used for treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.Visual evaluation under magnification shows minimal electrode wear with discoloration on the tip from activation.There are no manufacturing abnormalities visually 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.Upon connection, the temperature threshold of the controller defaulted to 45 degrees.During testing of the returned wand, the temperature did not rise above 27 degrees and did not cause the controller to alarm/overheat.The suction line was tested and performed as intended.The complaint could not be verified and the root cause could not be determined with confidence as the device did not overheat during functional evaluation.It is possible that there was not sufficient suction pressure in order to ensure adequate flow and circulation of saline solution to prevent unnecessary heating which could have caused the temperature to elevate and trigger the controller alarm.Likewise, the user may not have set the controller temperature threshold to the desired value.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: 8327762
• Report Number: 3006524618-2019-00090
• Device Sequence Number: 1915132
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: 00817470001761
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 09/26/2021
• Device Catalogue Number: ASCA5001-01
• Device Lot Number: 2020968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1