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

Catalog Number	EIC8875-01
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an unspecified procedure, the tip of the procise ez wand did not provide sufficient suction, as if the internal suction channel was partially blocked.The procedure was completed with a smith and nephew back up device with a delay greater than 30 minutes.No further complications were reported.
Event or Problem Description
It was reported that during an unspecified procedure, the tip of the (two) procise ez wand did not provide sufficient suction, as if the internal suction channel was partially blocked.The procedure was completed with a smith and nephew back up device with a delay greater than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).B5 updated.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.Visual inspection observed the two returned devices show no manufacturing abnormalities.Fluid is in the fluid lines.Electrodes have been used on both.Bio debris is present on both.One wand is bent from use.The devices were returned together and out of the original packaging.No packaging returned.A functional evaluation showed each opened device was tested and plugged into the controller and registered settings (7,3).Both wands produced plasma and coagulation as expected.Saline was drawn and returned through each evac line using a syringe with no flow problem.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 investigation.Factors that can contribute to the reported event include 1) the tissue attempted to be suctioned was too large, thereby causing a clog.2) insufficient suction pressure or saline flow to excavate tissue.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: 19402270
• Report Number: 3006524618-2024-00197
• Device Sequence Number: 6955376
• Product Code: GEI
• UDI-Device Identifier: 00817470000313
• UDI-Public: 00817470000313
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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): 06/21/2024

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: 2135641
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/03/2024; 06/21/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 06/03/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• 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