INSUFFLATION TUBE MAJ-590Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170061318), received between Dec 22, 2020 and Feb 15, 2021 — classified as 2 malfunctions.

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

• MalfunctionFeb 15, 2021Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING UNSPECIFIED TIMING, THE WHITE RESIDUE LIKE CALCIUM HYPOCHLORITE REMAINED IN THE TUBE OF THE SUBJECT DEVICE. THE USER HAS STERILIZED THE SUBJECT DEVICE BY NON-OLYMPUS STERILIZATION EQUIPMENT STERRAD, HOWEVER THE SUBJECT DEVICE IS NOT COMPATIBLE WITH STERILIZATION BY STERRAD. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11327071 ↗
• MalfunctionDec 22, 2020Device Reprocessing Problem; Device Reprocessing Problem

  THE DEVICE WAS NOT COMPATIBLE WITH THE LOW-TEMPERATURE PLASMA STERILIZATION SYSTEM. HOWEVER, THE USER REPROCESSED THE DEVICE BY LOW-TEMPERATURE PLASMA STERILIZATION SYSTEM. THERE IS A POSSIBILITY THAT THE DEVICE WAS USED WITH INSUFFICIENT REPROCESS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT INCLUDING THE INFECTION. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11053515 ↗

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