NA 72204925Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00885556643747), received between May 21, 2020 and Dec 24, 2022 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LIGHT GUIDE HAS BEEN DISPLAYING A YELLOW-TONE IMAGE, IN ADDITION THE SCREENS INDICATED THE FOLLOWING MESSAGE "INCOMPLETE WHITE BALANCE". THERE WAS A SURGICAL DELAY OF MORE THAN 30 MINUTES IN THE PROCEDURE AND IT WAS FINISHED WITH THE SAME FAULTY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16045841 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096459 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096435 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096424 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096366 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096355 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096327 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096326 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096304 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096232 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096199 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096194 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096158 ↗
• MalfunctionDec 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE "LIGHT GUIDE ORANGE (5MM X 12FT)" HAD A DARK SUBSTANCE AROUND THE CONNECTION POINT. THE CUSTOMER DISCUSSED THE INSTRUCTIONS FOR USE AND CONFIRMED THEY USING CORRECTLY 270°, 4 MINUTES, 30 COOL DOWN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096149 ↗
• InjuryMay 21, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE LIGHT GUIDE PEELED AFTER STERILIZATION FOR THE FIRST TIME. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10080542 ↗