MAUDE Adverse Event Report: ARTHROCARE CORPORATION INTELLIO SHIFT WIRED FOOT PEDAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290011
Medical Device Problem Codes	Degraded (1153); Electrical /Electronic Property Problem (1198); Self-Activation or Keying (1557); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, when one (1) wired foot pedal was pressed, it may work, but does not stop when unpressed, or it may not work when pressed.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
The reported device was received for evaluation.A visual inspection observed the vac pedal paint is all worn away from use.The ablate pedal is in a depressed state.A functional evaluation revealed when plugging in the pedal to a controller, the unit displays a button is pressed while plugging in, the ablate pedal lacks spring motion and is in a depressed state.Lifting the pedal up and plugging in the device, the pedal functions as normal.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.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 (improper cleaning and sterilization methods).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: INTELLIO SHIFT WIRED FOOT PEDAL
• 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: 24270316
• Report Number: 3006524618-2026-00054
• Device Sequence Number: 10120802
• Product Code: GEI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 72290011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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