NA 72204924Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556643730), received between Jul 9, 2019 and Nov 6, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE UNIVERSAL LIGHT GUIDE ORANGE WAS GETTING HOT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS DELAY OF 2 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20625916 ↗
• MalfunctionDec 4, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE UNIVERSAL LIGHT GUIDE'S CABLE BROKE. THERE WAS NO BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9413438 ↗
• MalfunctionJul 9, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE UNIVERSAL LIGHT GUIDE CABLE WAS DAMAGED AFTER PASSING THROUGH THE STERILIZATION PROCESS AS THEY WERE FOUND STICKING AND OVERHEATING. THE FIRST STERILIZATION WAS MADE IN THE STERRAD; THE SECOND ONE, MADE BY THE HOSPITAL, IS UNKNOWN. AS THIS HAPPENED PRIOR TO ANY CASE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8774299 ↗
• MalfunctionJul 9, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE UNIVERSAL LIGHT GUIDE CABLE WAS DAMAGED AFTER PASSING THROUGH THE STERILIZATION PROCESS AS THEY WERE FOUND STICKING AND OVERHEATING. THE FIRST STERILIZATION WAS MADE IN THE STERRAD; THE SECOND ONE, MADE BY THE HOSPITAL, IS UNKNOWN. AS THIS HAPPENED PRIOR TO ANY CASE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8774298 ↗
• MalfunctionJul 9, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE UNIVERSAL LIGHT GUIDE CABLE WAS DAMAGED AFTER PASSING THROUGH THE STERILIZATION PROCESS AS THEY WERE FOUND STICKING AND OVERHEATING. THE FIRST STERILIZATION WAS MADE IN THE STERRAD; THE SECOND ONE, MADE BY THE HOSPITAL, IS UNKNOWN. AS THIS HAPPENED PRIOR TO ANY CASE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8774297 ↗