AUXILIARY WATER INLET CAP MAJ-215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170071713), received between Aug 10, 2022 and Sep 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K131780); 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE GASTROINTESTINAL VIDEOSCOPE (GIF-1100) WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION (MANUFACTURER REPORT NUMBER: 9610595-2022-01693). UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE AUXILIARY WATER INLET CAP, MAJ-215 (SUBJECT DEVICE), WAS MISSING. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION OF MISSING AUXILIARY WATER INLET CAP. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462543 ↗
• MalfunctionAug 10, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT, DURING NORMAL USE OF THE SUBJECT DEVICE, DARKENING OCCURRED IN THE PART THAT BLOCKED THE SECONDARY WATER SUPPLY. DURING CLEANING, IT WAS BLACK WHEN MEDICAL STAFF CHECKED IF IT WAS CLEAN. THERE WAS NO EFFECT ON A PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198670 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131780. One submission often covers many models, so check the product and lot details in each record.

• Z-1210-2024 · Jan 11, 2024 · Open, Classified
  Colonoscope, Model Number PCF-H190DL.
• Z-0419-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0417-2024 · Oct 16, 2023 · Open, Classified
  GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0418-2024 · Oct 16, 2023 · Open, Classified
  PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
• Z-0416-2024 · Oct 16, 2023 · Open, Classified
  GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Z-0415-2024 · Oct 16, 2023 · Open, Classified
  CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
• Z-0341-2024 · Sep 25, 2023 · Open, Classified
  Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-
• Z-0056-2025 · Sep 14, 2023 · Open, Classified
  EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancil