SafeLight 0233050100Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327051650), received between Jul 8, 2020 and Feb 7, 2023 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Output Problem” (18 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 2, 2023Class IIOpen, Classified

   Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.

   Z-1474-2023 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Electrical /Electronic Property Problem; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

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

  MAUDE report 16310860 ↗
• MalfunctionFeb 6, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308858 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366402 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366396 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366361 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366346 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366325 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366303 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366295 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366293 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366287 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14356222 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14356213 ↗
• MalfunctionMay 11, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14356052 ↗
• InjuryNov 1, 2021Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS BURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Superficial (First Degree) Burn

  MAUDE report 12733145 ↗
• MalfunctionJul 21, 2021Thermal Decomposition of Device; Failure to Shut Off; Failure to Shut Off

  IT WAS REPORTED THAT THERE WAS DRAPE BURN.

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

  MAUDE report 12202334 ↗
• MalfunctionFeb 23, 2021Unintended Power Up; Thermal Decomposition of Device; Unintended Power Up

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

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

  MAUDE report 11369244 ↗
• MalfunctionFeb 10, 2021Output Problem; Output Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT FOR 30 SECONDS.

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

  MAUDE report 11310898 ↗
• MalfunctionFeb 10, 2021Output Problem; Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT FOR 30 SECONDS.

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

  MAUDE report 11310873 ↗
• MalfunctionFeb 10, 2021Output Problem; Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT FOR 30 SECONDS.

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

  MAUDE report 11310816 ↗
• MalfunctionFeb 10, 2021Output Problem; Electrical /Electronic Property Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LIGHT LOSS FOR 30 SECONDS.

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

  MAUDE report 11310807 ↗
• MalfunctionJul 8, 2020No Display/Image; Optical Obstruction; No Display/Image; Optical Obstruction

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT (IMAGE).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10248414 ↗