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

Catalog Number	EIC8875-01
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified procedure, the procise coblator ii was smoking and overheating as soon as it was attached, and water started to be used.The procedure was completed using a different surgical technique.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: case-2xxx-xxx.The reported device was received for evaluation.A visual inspection observed two devices were returned together in the same bag without any original packaging and no labels.The returned devices show no manufacturing abnormalities.Fluid is in the fluid lines of both devices.Electrodes of both devices have been used.One wand is bent from use.Both wands show signs of being in contact with a sharp instrument such as a grasper.Bio debris is present on both.A functional evaluation showed both the devices were tested and plugged into the controller and registered settings (7,3).Coagulation and plasma were generated as intended.There was no smoke or overheating observed during functional testing.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 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 product evaluation process.Factors that can contribute to the reported event include: 1) used non-conductive media.2) ensure that the wand tip (including return electrode) is completely surrounded by conductive media during use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: PROCISE EZ VIEW 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: 19764695
• Report Number: 3006524618-2024-00271
• Device Sequence Number: 15572957
• Product Code: GEI
• UDI-Device Identifier: 00817470000313
• UDI-Public: 00817470000313
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: EIC8875-01
• Device Lot Number: 2139847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2023
• 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
• Patient Sex: Unknown