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

Catalog Number	ASCA5001-01
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an unspecified procedure, the ambient megavac wand was displaying an ¨7 error¨ message when connected to the terminal.The procedure was completed with a s+n back up device.There was a surgical delay greater than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection observed the returned device shows no manufacturing abnormalities.The evac line is cloudy and has a strong chemical smell.Bio debris is present.The device was out of the original packaging.No packaging returned.A functional evaluation revealed an e7 error was generated when the wand was connected after the controller was powered on.When used with a bypass box, coagulation and plasma were generated as intended.The resistance measured at 1.04 kilo ohms.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was associated with reuse of a single device.Factors that could have contributed to the reported event include: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.(3) an issue with one of the concomitant devices in use at the time of this complaint event.Based on this investigation, the need for corrective action is not indicated.

• 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
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19697586
• Report Number: 3006524618-2024-00252
• Device Sequence Number: 18060821
• Product Code: GEI
• UDI-Device Identifier: 00817470001761
• UDI-Public: 00817470001761
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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 Catalogue Number: ASCA5001-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown