SafeLight 0233050087Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07613327161618), received between Mar 4, 2019 and Sep 24, 2026 — classified as 59 malfunctions.

The most frequently reported specific device problem is “Output Problem” (25 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889815 ↗
• MalfunctionSep 24, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889811 ↗
• MalfunctionSep 24, 2026Optical Problem

  It was reported that during a pediatric laparoscopic procedure, the light output from the light source unit suddenly turned off. Although the front panel remained illuminated, pressing the ON button did not restore the light output. The ring indicator and light intensity display on the panel remained lit, and the light intensity could still be adjusted. When the power to the unit was turned OFF and then ON again, the light output was restored. However, after being used for a period of time, the same issue recurred. This phenomenon reportedly occurred approximately 3 to 5 times during the procedure. The exact duration of each occurrence is unknown. The light output did not resume automatically. In each instance, the issue was resolved by turning the device off and back on. The procedure was completed with the same device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889799 ↗
• MalfunctionSep 24, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889798 ↗
• MalfunctionSep 24, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889497 ↗
• MalfunctionSep 24, 2026Optical Problem

  It was reported that during a pediatric laparoscopic procedure, the light output from the light source unit suddenly turned off. Although the front panel remained illuminated, pressing the ON button did not restore the light output. The ring indicator and light intensity display on the panel remained lit, and the light intensity could still be adjusted. When the power to the unit was turned OFF and then ON again, the light output was restored. However, after being used for a period of time, the same issue recurred. This phenomenon reportedly occurred approximately 3 to 5 times during the procedure. The exact duration of each occurrence is unknown. The light output did not resume automatically. In each instance, the issue was resolved by turning the device off and back on. The procedure was completed with the same device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888857 ↗
• MalfunctionJan 8, 2026Optical Problem; Output Problem

  IT WAS REPORTED THAT LIGHT DISAPPEARED ABOUT TWO HOURS INTO THE PROCEDURE. PROCEDURE COMPLETED USING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24004363 ↗
• MalfunctionSep 4, 2025Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT THE SAFELIGHT ADAPTERS WERE NOT POWERING THE LIGHT OFF WHEN DISCONNECTED.

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

  MAUDE report 22973180 ↗
• MalfunctionSep 4, 2025Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT SAFELIGHT ADAPTERS NOT POWERING THE LIGHT OFF WHEN DISCONNECTED.

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

  MAUDE report 22972381 ↗
• MalfunctionJul 24, 2025Optical Problem; Output Problem; Optical Problem; Output Problem

  THE ADAPTER WAS NOT RECOGNIZED AND THE LIGHT SOURCE STOPPED WORKING. THE PERMANENT MAGNET HAD LOST ITS MAGNETIC FORCE. THEREFORE, THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22594022 ↗
• MalfunctionJun 25, 2025Optical Problem; Output Problem; Optical Problem; Output Problem

  IT WAS REPORTED BY THE CUSTOMER THAT "DURING DISSECTION ON A LAPAROSCOPIC HYSTERECTOMY, THE STRYKER TOWER ANNOUNCED "LIGHT SOURCE DEACTIVATED". IT THEN CONTINUED TO STROBE BETWEEN ON AND OFF, ALTERNATING SAYING "LIGHT SOURCE ACTIVATED AND LIGHT SOURCE DEACTIVATED". GYNE CHARGE NURSE WAS QUICKLY RETRIEVED FOR THE SITUATION. A NEW TOWER AND CAMERA AND LAPAROSCOPE WERE QUICKLY ACQUIRED, BUT AFTER HOOKING THEM UP, THE SAME PROBLEM OCCURRED. THE TEAM THEN TRIED A NEW LIGHT CORD, AND THIS FIXED THE PROBLEM. THE LIGHT CORD WAS ISOLATED IN A ZIPLOC BAG WITH A NOTE TO RETURN IT TO THE CNL UPON CLEANING". THEREFORE, THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331966 ↗
• MalfunctionDec 23, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21004542 ↗
• MalfunctionAug 23, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055504 ↗
• MalfunctionAug 23, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055028 ↗
• MalfunctionAug 23, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052265 ↗
• MalfunctionAug 23, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052263 ↗
• MalfunctionAug 23, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20052261 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037937 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036578 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036427 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036120 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034391 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034304 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034072 ↗
• MalfunctionAug 22, 2024Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  THIS EVENT WAS INITIALLY REPORTED AS A MALFUNCTION FOR A THERMAL EVENT. UPON ADDITIONAL INFORMATION PROVIDED, IT WAS REPORTED THAT THE DEVICE IS MISSING A MAGNET, THEREFORE IT WOULD NOT HAVE BEEN ABLE TO BE TURNED ON. THIS EVENT IS NO LONGER REPORTABLE. THIS EVENT DESCRIPTION MOST LIKELY INDICATES "NO LIGHT OUTPUT". THE REVIEW OF HISTORICAL COMPLAINT DATA, RISK DOCUMENTATION, AND THE REPORTED INFORMATION REGARDING THIS EVENT DO NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD BE LIKELY TO RESULT IN A SERIOUS INJURY. NO ADVERSE CONSEQUENCES WERE REPORTED, IT DOES NOT SEEM LIKELY THAT ADVERSE CONSEQUENCES WOULD RESULT IF IT WERE TO RECUR. NO REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033476 ↗