MAUDE Adverse Event Report: ARTHROCARE CORPORATION MICROBLATOR 30 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC4050-01
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Tissue Irritation (4912)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a knee arthroscopy, the surgeon observed an unknown yellow foreign substance on the tip of the microblator wand through the arthroscope image.When the surgeon wiped the tip with gauze, he noticed that a small amount of the yellow substance was transferred onto the gauze.Also, the surgeon reported that after the procedure, the patient¿s inflammation level was found to be elevated.The procedure was resumed, with a delay greater than 30 minutes, using an equivalent sn back-up.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected information on: g2 & h6 (clinical symptoms).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 clinical review states that an intraoperative photo was provided for review and confirm the reported substance.All documents and images provided as of this date have been reviewed and considered, and unless noted, do not contribute to the clinical/medical investigation.Based on the information provided, the clinical root cause or the source of the reported ¿yellow substance¿ could not be determined.What the yellow substance was, or its biocompatibility is unknown, and the possibility of infection, localized pain/discomfort, cannot be ruled out.It also cannot be ruled out that the material was from the microblator.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 any additional information related to this event is received in the future, this investigation will be reopened for further assessment.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11 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 has signs of use.The electrode at the tip has been bent to one side.No substances are seen at the tip of the device.The device was plugged into the controller and registered settings (1,6).The wand had no issues producing plasma or activating coag with its bent electrode.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification 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 clinical review states that an intraoperative photo was provided for review and confirm the reported substance.Based on the information provided, the clinical root cause or the source of the reported ¿yellow substance¿ could not be determined.What the yellow substance was, or its biocompatibility is unknown, and the possibility of infection, localized pain/discomfort, cannot be ruled out.It also cannot be ruled out that the material was from the microblator.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.

• Brand Name: MICROBLATOR 30 ICW
• 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: 23703697
• Report Number: 3006524618-2025-00686
• Device Sequence Number: 10595854
• Product Code: GEI
• UDI-Device Identifier: 00817470003123
• UDI-Public: 817470003123
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: AC4050-01
• Device Lot Number: 2177719
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 03/19/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/09/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2025
• 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