SUCTION TUBE MAJ-591Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170061325), received between Jul 7, 2022 and Jul 14, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K014166); 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.

• MalfunctionJul 14, 2022Decrease in Suction; Decrease in Suction

  A USER FACILITY REPORTED TO OLYMPUS, THE SUCTION TUBE EXPERIENCED PNEUMOPERITONEUM PRESSURE DECREASED. THE EVENT OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE SMOKE EXHAUST FUNCTION WAS ACTIVATED, AND THE PRESSURE DECREASED EVEN THOUGH THE FOOT SWITCH WAS NOT ENGAGED. IT WAS REPORTED THAT, AFTER THE AIR WAS SENT, THE PRESSURE WAS RELEASED, AND THE PROCEDURE WAS CONTINUED AND COMPLETED. THE CUSTOMER REPORTED THAT THIS ISSUE HAS OCCURRED SEVERAL TIMES. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15010085 ↗
• MalfunctionJul 7, 2022Decrease in Suction; Decrease in Suction

  THE CUSTOMER REPORTED THAT HIS OLYMPUS SUCTION TUBE WAS EXPERIENCING A SUCTION PRESSURE ISSUE DURING A DIAGNOSTIC PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE SMOKE EXHAUST FUNCTION WAS ACTIVATED AND THE PRESSURE DECREASED EVEN THOUGH THE FOOT SWITCH WAS NOT ENGAGED. REPORTEDLY, AFTER THE AIR WAS SENT AGAIN, THE PRESSURE WAS RELEASED AND THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY PATIENT HARM USING THE SUBJECT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014166. One submission often covers many models, so check the product and lot details in each record.

• Z-1354-2026 · Jan 16, 2026 · Open, Classified
  Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic obs