MAUDE Adverse Event Report: ARTHROCARE CORPORATION EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA5874-01
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tonsillectomy, the evac 70 xtra coblator ii wand was arcing while using the settings 9-5.The procedure was successfully completed with a surgical delay of 10 minutes using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Fluid is in the fluid line.Electrodes have been used.Bio debris is present.Product was out of the original packaging.No packaging returned.A functional evaluation showed the opened device was tested and plugged into the controller and registered settings (7,3).The wand produced plasma with no arcing at levels 7,3 and 9,5.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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 could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
Event or Problem Description
It was reported that during a tonsillectomy, the evac 70 xtra coblator ii wand was arcing while using the settings 9-5.The settings were moved to 8-4 and it helped, but still noticed arcing.The procedure was completed with a surgical delay of 10 minutes using a back-up device.No further complications were reported.

• Brand Name: EVAC 70 XTRA HP COBLATOR II
• 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: 16335121
• Report Number: 3006524618-2023-00055
• Device Sequence Number: 6845493
• Product Code: GEI
• UDI-Device Identifier: 00817470004007
• UDI-Public: 00817470004007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: 01/13/2024
• Device Model Number: EICA5874-01
• Device Catalogue Number: EICA5874-01
• Device Lot Number: 2065947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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