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

Catalog Number	EIC8898-01
Medical Device Problem Codes	Break (1069); Degraded (1153); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal wire of the procise wand broke.It is unknown when the event took place, if there was patient involvement or if there was a delay.There was a back up device available and no further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H10, h3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Product was out of the original packaging.No packaging returned.The tip is worn from use.The electrode is thin from use.The middle portion of the electrode is worn away.The shaft has been bent without using a proper tool causing it to have dents in it.The opened device was tested and plugged into the controller and registered settings (7,3).The wand produced plasma with its remaining electrode and had no issues activating coag.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 has been associated with component failure.Factors that could have contributed to the reported event include using the wand above default output settings or pressing the tip against hard or bony surfaces, thus causing the electrodes to become eroded extensively.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: PROCISE MAX 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22110153
• Report Number: 3006524618-2025-00254
• Device Sequence Number: 12581849
• Product Code: GEI
• UDI-Device Identifier: 00817470007473
• UDI-Public: 00817470007473
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 08/17/2026
• Device Catalogue Number: EIC8898-01
• Device Lot Number: 2129042
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2023
• 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