Injection tube MH-946Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170286421), received between Nov 13, 2020 and Nov 16, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REQUESTED AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST CONDUCT A REPROCESSING IN-SERVICE. WHILE ONSITE, IT WAS DISCOVERED THE CUSTOMER WAS NOT REPROCESSING THE AUXILIARY WATER TUBE, SUCTION CLEANING ADAPTER, AND INJECTION TUBE AFTER EACH USE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18146513 ↗
• MalfunctionJan 24, 2022Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, IT WAS FOUND THAT THE SUBJECT DEVICE HAD NOT BEEN REPROCESSED. THE INCORRECT REPROCESSED (REPROCESSED ACCORDING TO A PROCEDURE DIFFERENT FROM THE INSTRUCTION MANUAL) SUBJECT DEVICE WAS USED. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333219 ↗
• MalfunctionNov 13, 2020Microbial Contamination of Device; Microbial Contamination of Device

  A TRAINER OF THE (B)(6) NURSE ASSOCIATION INFORMED AN OLYMPUS REPRESENTATIVE THAT A NURSE TOLD THE TRAINER THAT THE NURSE HAD EXPERIENCED HEAVY CONTAMINATION OF THE DEVICE. THE CONVERSATION OCCURRED DURING REPROCESSING TRAINING PROVIDED BY THE TRAINER. NO DETAILED INFORMATION IS AVAILABLE REGARDING THE EXACT CUSTOMER NAME, NUMBER OF CONTAMINATED MH-946S OR CONTAMINATION RESULTS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10834210 ↗