PRECISION 0220220000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327051322), received between Sep 10, 2018 and Jun 5, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Output Problem” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K082813); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionJun 5, 2026Overheating of Device; Activation Problem

  IT WAS REPORTED THAT LIGHT CORD TURNED ON WITHOUT US PRESSING THE STANDBY BUTTON, BURNED A HOLE IN THE DRAPE.

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

  MAUDE report 25413903 ↗
• MalfunctionJun 3, 2026Optical Problem

  IT WAS REPORTED THAT AFTER INSTALLING THE FIBER OPTIC CABLE, NO LIGHT IS BEING DETECTED FROM THE PRECISION LIGHT SOURCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383260 ↗
• MalfunctionOct 15, 2025Overheating of Device; Smoking; Sparking; Temperature Problem; Explosion; Overheating of Device; Smoking; Sparking; Temperature Problem; Explosion

  IT WAS REPORTED THAT THE OPERATING ROOM AT REPORTED A TECHNICAL FAILURE OF THE PRECISION LED LIGHT SOURCE CONSOLE (REF. 0220220000) DURING A PROCEDURE. THE INCIDENT REPORTEDLY CAUSED AN EXPLOSION, ACCOMPANIED BY SMOKE AND SPARKS.

  Patient problems: Insufficient Information

  MAUDE report 23300922 ↗
• MalfunctionJan 28, 2025Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251810 ↗
• MalfunctionAug 2, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19899718 ↗
• MalfunctionDec 6, 2023Circuit Failure; Temperature Problem; Circuit Failure; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18277684 ↗
• MalfunctionOct 24, 2023Optical Problem; Activation Problem; Optical Problem; Activation Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999557 ↗
• MalfunctionMay 9, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899268 ↗
• MalfunctionMar 27, 2023Energy Output Problem; Output Problem; Energy Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624702 ↗
• MalfunctionFeb 22, 2023Poor Quality Image; Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421649 ↗
• MalfunctionFeb 13, 2023Output Problem; Temperature Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

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

  MAUDE report 16361849 ↗
• MalfunctionDec 28, 2022Output Problem; Poor Quality Image; Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16065427 ↗
• MalfunctionJul 7, 2022Output Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

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

  MAUDE report 14945918 ↗
• MalfunctionJun 21, 2022Smoking

  IT WAS REPORTED THAT THE DEVICE WAS EMITTING SMOKE.

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

  MAUDE report 14762651 ↗
• MalfunctionMay 18, 2022No Device Output; Output Problem; No Device Output

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429739 ↗
• MalfunctionNov 16, 2021Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrostatic Discharge

  IT WAS REPORTED THAT THE USER WAS SHOCKED. PLEASE NOTE, IT WAS CONFIRMED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824741 ↗
• MalfunctionApr 1, 2021Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

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

  MAUDE report 11602781 ↗
• MalfunctionDec 26, 2019Erratic or Intermittent Display; Unexpected Shutdown; Erratic or Intermittent Display; Unexpected Shutdown

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT (IMAGE) DURING A PROCEDURE. PLEASE NOTE, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520593 ↗
• MalfunctionMay 2, 2019Loss of Data

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573544 ↗
• MalfunctionApr 3, 2019No Display/Image

  IT WAS REPORTED THAT THE LIGHT SOURCE HAD LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478957 ↗
• MalfunctionApr 2, 2019No Display/Image

  IT WAS REPORTED THAT THE LIGHT SOURCE HAD LOSS OF IMAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474230 ↗
• MalfunctionSep 10, 2018Overheating of Device

  IT WAS REPORTED TTHAT THE DEVICE EMITTED ABNORMAL HEAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7862670 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082813. One submission often covers many models, so check the product and lot details in each record.

• Z-1474-2023 · Mar 2, 2023 · Open, Classified
  SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200