MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE XP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA8872-01
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ent procedure using a procise xp wand, the coagulation function was not working effectively and producing the coag result that is normally produced.Intra-operatively, it was noticed that there was a visible burn on the lower right side of the lip.The wound was not staged.In recovery, the tissue was intact, grey-white color, no drainage.The burn was treated with vaseline.The procedure was completed with a non-significant surgical delay using a back-up device.No further complications were reported.The patient was discharged.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned instrument shows no manufacturing abnormalities.Two of the electrode wires are partially detached.Product was out of the original packaging.No packaging returned.The device was plugged into the controller and registered settings (7,3).The wand was able to generate plasma and coagulation with the remaining electrode, loss of power observed.Saline and suction both performed as intended.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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 states after a medical review of the case, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.Based on the information provided, the surgeon used two different procise xp wands in the procedure, and it was reported the coag function was not working effectively.Per report, intra-operatively the patient had an un-staged wound on the lower right side of the lip.However, no photos were provided.According to the report, the tissue on the patient¿s right side of the lip was intact, grey, white in color, without drainage and it was treated with vaseline.It was reported the procedure was completed with a non-significant surgical delay using a back-up device, without further complications.The impact to the patient to the patient beyond the reported burns, the vaseline treatment, the surgical delay, pending wound consult, and the pending follow-up with the provider cannot be determined since this adverse event has not been reported as resolved.Since it was reported the patient was discharged home day of the procedure per usual expected disposition, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessment.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported even include: 1) activating the device above recommended settings for prolonged periods of time.No containment or corrective actions are recommended at this time.

• Brand Name: PROCISE XP COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15676251
• Report Number: 3006524618-2022-00463
• Device Sequence Number: 12355555
• Product Code: GEI
• UDI-Device Identifier: 00817470003727
• UDI-Public: 00817470003727
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 06/02/2023
• Device Model Number: EICA8872-01
• Device Catalogue Number: EICA8872-01
• Device Lot Number: 2056653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2020
• 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: 21 YR
• Patient Sex: Unknown