LUMINELLE DTx Hysteroscopy System LumDTX-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00853277008046), received between Mar 21, 2023 and Aug 15, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THEY NOTICED THE BLUE CASING OF THE SCOPE IS STARTING TO TEAR. THEY REPORTED THE SCOPE HAD ONLY BEEN USED IN TWO CASES. THE CUSTOMER PROVIDED PHOTOS OF THE PHYSICAL DAMAGE TO THE SCOPE STICK. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552750 ↗
• MalfunctionAug 15, 2023Erratic or Intermittent Display; No Display/Image; Deformation Due to Compressive Stress; Erratic or Intermittent Display; No Display/Image; Deformation Due to Compressive Stress

  THE CUSTOMER REPORTED THAT THE LOANER SCOPE WAS DAMAGED DURING A PATIENT PROCEDURE. THE CUSTOMER EXPLAINED THAT THERE WAS SEVERE DAMAGE TO THE BLUE SCOPE STICK, BUT DID NOT SPECIFY HOW THE DAMAGE OCCURRED. THERE WERE NO PATIENT ADVERSE EVENTS DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552749 ↗
• MalfunctionAug 15, 2023Erratic or Intermittent Display; Image Display Error/Artifact; Improper or Incorrect Procedure or Method; Erratic or Intermittent Display; Image Display Error/Artifact; Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED THAT THEY WERE EXPERIENCING INTERMITTENT IMAGES FROM THE SCOPE ON THE MONITOR. THE CUSTOMER SENT IMAGES OF A PHYSICAL DAMAGE THEY NOTICE AS WELL. CLEAR DAMAGE TO THE FIBER OPTIC STICK WAS VISIBLE IN THE IMAGES. THE FIBER OPTIC CABLE WAS VISUALLY AND FUNCTIONALLY TESTED TO CONFIRM THE PHYSICAL AND FUNCTIONAL DAMAGE SEEN BY THE CUSTOMER. THE USAGE COMMUNICATED BY THE CUSTOMER WAS RECREATED IN AN ATTEMPT TO RECREATE THE DAMAGE. THE DAMAGE COULD NOT BE RECREATED USING THE SAME INSTRUMENTATION USED WITH THE DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552729 ↗
• MalfunctionMar 21, 2023Device Handling Problem; Device Handling Problem

  THE CUSTOMER REPORTED DURING A PHONE CALL THAT THEY WERE UNABLE TO PRODUCE AN IMAGE IN THEIR MONITOR AFTER ASSEMBLING THE SYSTEM. THE CUSTOMER INDICATED THAT THE SYSTEM FAILURE WAS CAUGHT PRIOR TO BE BEING USED WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587911 ↗
• MalfunctionMar 21, 2023Connection Problem; Premature Separation; Connection Problem; Premature Separation

  SCOPE AND SHEATH(S) DO NOT CONSISTENTLY ATTACH TO THE DEVICE. WHILE CONDUCTING PROCEDURES, THE SCOPE AND SHEATH(S) BECOME DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587901 ↗
• MalfunctionMar 21, 2023Poor Quality Image; Poor Quality Image

  IN A PRE-SALE DEMONSTRATION, THE SURGEON WAS USING THE LUMINELLE DTX SYSTEM FOR A CYSTOSCOPY PROCEDURE AND THE SALES REPRESENTATIVE REPORTED THAT THE VISIBILITY WAS VERY DARK. THE SALES REPRESENTATIVE AND SURGEON SAID THAT IT WAS DIFFICULT TO VIEW THE BLADDER UNLESS THE SCOPE WAS VERY CLOSE TO THE BLADDER WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587900 ↗