THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope THD Light - Scope LED Large Rectoscope with inflation bulb SterileRecalls & reported problems
Thd SPA · The Light-Score LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma. The Light-Score LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field. The Light-Score LED rectoscope is ready-to-use and it also available with an inflating included · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033737710623), received between Jul 7, 2026 and Jul 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2026Tear, Rip or Hole in Device Packaging
THE (B)(6) REPORTED A PRODUCT ISSUE TO FDA CONCERNING A THD LIGHT-SCOPE MAXI-RECTO DEVICE WITH A BROKEN PLASTIC PACKAGING. THE ISSUE WAS IDENTIFIED PRIOR TO DEVICE USE DURING A DAVINCI ROBOT SIGMOIDECTOMY PROCEDURE. NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED. THE PROBLEM WAS RESOLVED BY OPENING A NEW UNIT, ALLOWING THE PROCEDURE TO BE COMPLETED AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25731275 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.