n.a. 495NCSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04048551001141), received between Aug 8, 2019 and Mar 25, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS LEFT ON TOP OF THE DRAPES AND THE PATIENT WAS BURNT ON THE FACE.

  Patient problems: Burn(s)

  MAUDE report 21691053 ↗
• InjuryMar 25, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS LEFT ON TOP OF THE DRAPES AND THE PATIENT WAS BURNT ON THE FACE.

  Patient problems: Burn(s)

  MAUDE report 21689182 ↗
• MalfunctionFeb 20, 2025Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem; Loose or Intermittent Connection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "WHILST OPERATING, THE FIBER OPTIC CABLE FALL OFF/COME LOOSE FROM THE LIGHT POST ON THE TELESCOPE. THERE WAS NO HARM TO THE PATIENT OR USER". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426208 ↗
• InjuryJan 23, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS LEFT ON TOP OF THE DRAPES AND THE PATIENT WAS BURNT ON THE FACE.

  Patient problems: Burn(s)

  MAUDE report 21222398 ↗
• InjuryJan 23, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS LEFT ON TOP OF THE DRAPES AND THE PATIENT WAS BURNT ON THE FACE.

  Patient problems: Burn(s)

  MAUDE report 21222373 ↗
• InjuryMar 10, 2023Overheating of Device; Improper or Incorrect Procedure or Method; Overheating of Device; Improper or Incorrect Procedure or Method

  THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE SURGEON PLACED THE WARM LIGHT CARRIER ON THE PATIENT. THE PATIENT SUFFERED BURNS. BECAUSE THE PATIENT SUFFERED BURNS, THE CASE IS CLASSIFIED AS REPORTABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 16526704 ↗
• InjuryMar 10, 2023Overheating of Device; Overheating of Device

  THE EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE SURGEON PLACED THE WARM LIGHT CARRIER ON THE PATIENT. THE PATIENT SUFFERED BURNS. BECAUSE THE PATIENT SUFFERED BURNS, THE CASE IS CLASSIFIED AS REPORTABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 16526455 ↗
• InjuryAug 8, 2019Use of Device Problem; Use of Device Problem

  ALLEGEDLY, A PATIENT UNDERGOING A TOTAL MASTECTOMY PROCEDURE SUSTAINED TWO BURNS, ONE SECOND DEGREE BURN AND ONE A THIRD DEGREE BURN.

  Patient problems: Burn(s)

  MAUDE report 8874337 ↗