Tricera™ Controller R-10001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00859273007014), received between Feb 8, 2023 and Apr 29, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Frayed; Loose or Intermittent Connection

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAD AN ISSUE WITH THE FOOTWSWITCH, THERE WAS A WIRE FRAYED. THE UNIT HAD WIRES EXPOSED/FRAYED AND A DANGLING STRAIN RELIEF THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029013 ↗
• MalfunctionNov 4, 2024Material Frayed; Key or Button Unresponsive/not Working; Material Frayed; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING SET UP, THE PEDALS OR BUTTONS ON FOOTSWITCH NO WORKED, CHANGED OVER FOOTSWITCH AND ALL OK. ON FURTHER INSPECTION THERE WERE SOME EXPOSED WIRES ON THE CABLE, METAL AND COLORED WIRES WERE VISIBLE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599192 ↗
• MalfunctionJun 25, 2024Material Frayed; Device Difficult to Program or Calibrate; Pressure Problem; Material Frayed; Device Difficult to Program or Calibrate; Pressure Problem

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604932 ↗
• MalfunctionFeb 8, 2023Connection Problem; Connection Problem

  IT IS REPORTED THAT THE FOOT PEDAL DOES NOT GET RECOGNIZED WHEN IT IS PLUGGED IN. NO HARM OR DELAY WAS REPORTED. AT PRODUCT EVALUATION/INVESTIGATION THERE WAS CORROSION ON THE TIP OF SEVERAL PINS, SALINE CORROSION ON ALL WIRES AND A DISCONNECTED CENTER WIRE. EXPOSED WIRES WERE PRESENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16329693 ↗