MAUDE Adverse Event Report: ARTHROCARE CORPORATION PROCISE EZ COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EIC8870-01
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	Corneal Clouding/Hazing (1878)
Date of Event	06/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a bilateral dcr procedure (dacryocystorhinostomy), it was observed by the operators that the precise ez coblator wand diffused electric current into the lower cornea of the patient causing stromal scar inferior right off optical axis.A slight white spot appeared in the lower cornea, it appeared to be superficial.The procedure was completed using cold instruments with no surgical delay.The patient is in healing progress as the lesion still present using ointment and medication applied to the injured eye as recommended by the ophthalmologist.No further complications were reported.
Additional Manufacturer Narrative
A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.The instructions for use were 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 that based on the information provided we are currently unable to rule out a user technique vs procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the instructions for use were adhered to; however, it does caution that ¿procise plasma wand devices are contraindicated in the following: non-endoscopic procedures for functional endoscopic sinus surgery¿ and ¿due to the smaller anatomies of certain patients, carefully monitor the surrounding tissues to ensure tissue ablation is localized to the targeted tissue.¿ the patient impact was determined to be the reported change in surgical technique with the use of the cold instruments to complete the procedure which may extend the patients¿ recovery time, the eye lesion, and the use of medication for treatment.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
The reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.The fluid delivery connector/system and power line has been cut from the device.Electrodes have been used.Debris is on and around the electrode.The electrode has been heavily used with erosion and damage to an edge.Product was out of the original packaging.No packaging returned.A functional evaluation could not be performed due to the power line being cut from the device.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.The instructions for use were 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 that based on the information provided we are currently unable to rule out a user technique vs procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.The instructions for use does caution that ¿precise plasma wand devices are contraindicated in the following: non-endoscopic procedures for functional endoscopic sinus surgery¿ and ¿due to the smaller anatomies of certain patients, carefully monitor the surrounding tissues to ensure tissue ablation is localized to the targeted tissue.¿ the root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include the electrodes came into contact with a conductive medium, such as saline.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: PROCISE EZ 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: 19913781
• Report Number: 3006524618-2024-00302
• Device Sequence Number: 8094970
• Product Code: GEI
• UDI-Device Identifier: 00817470000450
• UDI-Public: 00817470000450
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2024

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: 01/16/2026
• Device Catalogue Number: EIC8870-01
• Device Lot Number: 2110397
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 09/16/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/26/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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: Required Intervention; Other
• Patient Age: 5 YR
• Patient Sex: Unknown
• Patient Weight: 22 KG