LED POWER 20161420-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551288900), received between Feb 10, 2023 and Jan 10, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 10, 2025Energy Spectrum Incorrect; Smoking; Energy Spectrum Incorrect; Smoking

  IT WAS REPORTED THAT " THERE WAS A SMOKY SMELL. SMOKE WAS COMING OUT. THE OPERATION WAS COMPLETED WITH ANOTHER SURGICAL TOWER". THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21129507 ↗
• MalfunctionAug 15, 2024Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  IT WAS REPORTED THAT DURING A CYSTOSCOPY PROCEDURE ON (B)(6) 2024, THE SURGICAL TEAM ASKED FOR THE EQUIPMENT TO BE TURNED ON IN PREPARATION FOR THE CYSTOSCOPY. RIGHT AFTER THE EQUIPMENT WAS TURNED ON, THE SCRUB TECH NOTICED A SMOKY SMELL AND PICKED UP THE LIGHT CORD. AN INSPECTION OF THE DRAPES REVEALED A BURN HOLE. DRAPES WERE THEN PULLED BACK AND PATIENT'S SKIN WAS INSPECTED FOR ANY INJURY. FORTUNATELY, NO INJURY WAS OBSERVED BY THE SURGEON OR THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997563 ↗
• InjuryAug 3, 2023Inadequate or Insufficient Training; Human-Device Interface Problem; Inadequate or Insufficient Training; Human-Device Interface Problem

  IT WAS REPORTED AN EVENT PERTAINING TO A POWER LED AT (B)(6) HOSPITAL WHERE IT REPORTED THAT THE USER RECEIVED A BURN TO THEIR ARM WHEN DISCONNECTING THE SCOPE FROM THE LIGHT SOURCE BECAUSE THE METAL CONNECTOR TOUCHED THEIR ARM. THE USER RECEIVED FIRST AID TREATMENT. NO LASTING EFFECTS OF THE BURN INJURY. THE PAIN WAS INITIALLY KEPT COVERED BUT OTHERWISE MANAGED WITH FIRST AID. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17452968 ↗
• InjuryAug 3, 2023Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED AN EVENT PERTAINING TO A POWER LED AT TOWNLANDS HOSPITAL WHERE IT REPORTED THAT THE USER RECEIVED A BURN TO THEIR ARM WHEN DISCONNECTING THE SCOPE FROM THE LIGHT SOURCE BECAUSE THE METAL CONNECTOR TOUCHED THEIR ARM. THE USER RECEIVED FIRST AID TREATMENT. NO LASTING EFFECTS OF THE BURN INJURY. THE PAIN WAS INITIALLY KEPT COVERED BUT OTHERWISE MANAGED WITH FIRST AID. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17452964 ↗
• InjuryFeb 10, 2023Overheating of Device; Overheating of Device

  IT HAS BEEN REPORTED THE STAFF HAS RECEIVED BURNS FROM THE LIGHT LEAD CAUSED BY THIS DEVICE.

  Patient problems: Bradycardia

  MAUDE report 16354004 ↗
• InjuryFeb 10, 2023Overheating of Device; Overheating of Device

  IT HAS BEEN REPORTED THE STAFF HAS RECEIVED BURNS FROM THE LIGHT LEAD CAUSED BY THIS DEVICE.

  Patient problems: Burn(s)

  MAUDE report 16353971 ↗