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

Model Number	EICA5874-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a tonsillectomy and adenoidectomy procedure using an evac 70 xtra coblator ii wand, a burn was noticed in the mouth in an area where the tip was not activated at any point.The procedure was successfully completed with a surgical delay of 1-2 minutes using a back-up device.The burn was evaluated by a plastic surgeon, no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review found the provided medwatch form was reviewed.However, the information provided is insufficient to determine whether the patient¿s symptoms, signs or outcome are due or surgical condition or procedure, or to an adverse reaction to or experience with the device, one or more of its components, or its intended therapeutic action.Therefore, a user vs procedural variance cannot be rule out.Based on the information provided, the procedure was successfully completed with a surgical delay of 1-2 minutes using a back-up device without and further complications.Since it was reported the patient was discharged with a follow up with a plastic surgeon, the impact to the patient beyond that which has already been reported cannot be determined.Should any additional relevant medical information be provided, this case would be re-assessed.Visual inspection observed the returned instrument shows no manufacturing abnormalities.The device shows minimal signs of use, no burn or arc damage is seen on the device.Product was out of the original packaging.No packaging returned.A functional evaluation was performed on the opened device and plugged into the controller and registered settings (7,3).Which is expected.The wand produced plasma as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.

• 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: 16206695
• Report Number: 3006524618-2023-00043
• Device Sequence Number: 14491152
• Product Code: GEI
• UDI-Device Identifier: 00817470004007
• UDI-Public: 00817470004007
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2025
• Device Model Number: EICA5874-01
• Device Catalogue Number: EICA5874-01
• Device Lot Number: 2104604
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 06/22/2023; 07/12/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 06/23/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 27 KG