MAUDE Adverse Event Report: ARTHROCARE CORPORATION INTELLIO SHIFT WIRED FOOT PEDAL; ARTHROSCOPE

Catalog Number	72290011
Medical Device Problem Codes	Overheating of Device (1437); Self-Activation or Keying (1557); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an unknown procedure, the intellio foot pedal became stuck, it started running the wand on its own and burnt through one drape before being unplugged.Surgery was completed with a back-up device instead.There was a delay of 5 minutes, and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.Visual inspection observed minor rusting/liquid ingress under the foot pedal covers.Functional evaluation revealed no issues.None of the pedals or functions of the device got stuck on while activated.The damage to the device did not prevent functionality.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 one similar reported event.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 failure of a concomitant device.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: INTELLIO SHIFT WIRED FOOT PEDAL
• Common Device Name: ARTHROSCOPE
• 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: 22120530
• Report Number: 3006524618-2025-00262
• Device Sequence Number: 4172224
• Product Code: HRX
• UDI-Device Identifier: 00885556805015
• UDI-Public: 885556805015
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K232290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 72290011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown