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

Catalog Number	EICA8875-01
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, the procise ez view coblator wand malfunctioned.The black plastic sheath of the wand was sliced.There was a backup device available.No delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection observed the two returned devices show no manufacturing abnormalities.Fluid is in both the fluid lines.Electrodes have been used.Bio debris is present.One device has a cut in the black protective wrap that exposes the metal tube below.There are markings from being in contact with a sharp instrument.The other device only has markings from being in contact with a sharp instrument but no cuts.The devices were together out of the original packaging.No packaging returned.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.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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (impact event inconsistent with normal use).Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection show no manufacturing abnormalities.Fluid is in both the fluid lines.Electrodes have been used.Bio debris is present.The device has a cut in the black protective wrap that exposes the metal tube below.There are markings from being in contact with a sharp instrument.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.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 definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (impact event inconsistent with normal use).Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.H11: h2: corrected data on h10.

• 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: 20824810
• Report Number: 3006524618-2024-00520
• Device Sequence Number: 8955471
• Product Code: GEI
• UDI-Device Identifier: 00817470004335
• UDI-Public: 817470004335
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• 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,Followup
• Report Date (Section B): 01/07/2025

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: EICA8875-01
• Device Lot Number: 2159282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/27/2024; 01/03/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2024
• 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