SUCTION CLEANING AD MAJ-222Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170071386), received between Apr 6, 2023 and Apr 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201300); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE SUBJECT DEVICE WAS NOT BEING REPROCESSED CORRECTLY FOR THE TJF-Q190V. SHE REPORTED, IT IS UNKNOWN HOW LONG THE FACILITY WAS NOT REPROCESSING THE SUBJECT DEVICE. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16697083 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201300. One submission often covers many models, so check the product and lot details in each record.

• Z-0340-2024 · Sep 25, 2023 · Open, Classified
  Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-
• Z-2499-2023 · Jul 27, 2023 · Open, Classified
  Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.