Single Use Injector NM-400U-0423 (UDI 04953170259876)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170259876), received between Sep 8, 2020 and Dec 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Corroded” (4 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Corroded; Corroded

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705822 ↗
• MalfunctionDec 3, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR SHOWED SIGNS OF CORROSION NEAR THE NEEDLE TIP. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705790 ↗
• MalfunctionDec 3, 2025Corroded; Corroded

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR HAD A RUSTY NEEDLE. THIS WAS FOUND DURING PREPARATION FOR USE; THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705671 ↗
• MalfunctionDec 3, 2025Corroded; Corroded

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705533 ↗
• MalfunctionDec 13, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE INJECTOR EXHIBITED WITH FOREIGN STAINS STUCK INSIDE THE SHEATH FROM THE DISTAL END AREA. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20927426 ↗
• MalfunctionFeb 15, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE INJECTOR PACKAGING, WHICH WAS COMPLETELY CLOSED, WAS OPENED, THE INJECTOR WAS INTRODUCED INTO THE COLONOSCOPE, AND THE INFILTRATION WAS PERFORMED CORRECTLY. WHEN THE INJECTOR WAS INTRODUCED INTO THE COLONOSCOPE FOR THE SECOND TIME, THE NEEDLE COULD NO LONGER BE ACTIVATED AND INFILTRATION COULD NOT BE PERFORMED, SO THE THERAPEUTIC COLONOSCOPY WAS PROLONGED FOR 15 MINUTES, AND WAS SUBSEQUENTLY POSTPONED. THE POSTPONEMENT OF THE PROCEDURE DID NOT REQUIRE A HOSPITAL STAY FOR THE PATIENT. THE COLONOSCOPY WAS COMPLETED ON THE SAME DAY. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708676 ↗
• MalfunctionFeb 12, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE INJECTOR PACKAGING WHICH WAS COMPLETELY CLOSED, WAS OPENED, AND WHEN THE INJECTOR WAS INSERTED INTO THE COLONOSCOPE FOR THE FIRST TIME, THE INFILTRATION WAS PERFORMED CORRECTLY. HOWEVER, WHEN THE INJECTOR WAS INSERTED FOR THE SECOND TIME, THE NEEDLE COULD NO LONGER BE ACTIVATED AND INFILTRATION COULD NOT BE PERFORMED. THE ISSUE OCCURRED DURING THE THERAPEUTIC COLONOSCOPY PROCEDURE, AND IT WAS DELAYED BY 15 MINUTES AND WAS SUBSEQUENTLY POSTPONED. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691668 ↗
• MalfunctionFeb 5, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED, THE INJECTOR AND SHEATH SET THE NEEDLE WAS STUCK INSIDE THE PLASTIC CASE. THE ISSUE OCCURRED DURING THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. ANOTHER INJECTOR WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647859 ↗
• MalfunctionJan 25, 2024Failure to Discharge; Failure to Discharge

  IT WAS REPORTED, THE INJECTOR WAS CLOGGED AND THE NURSE COULD NOT INJECT THE LIQUID INTO THE PATIENT. THE CUSTOMER TRIED SEVERAL TIMES, AND DECIDE TO COMPLETE THE PROCEDURE WITH A DIFFERENT INJECTOR. THE ISSUE OCCURRED DURING A THERAPEUTIC COLONOSCOPY. THERE WERE NO REPORTS OF PATIENT HARM NOR WAS THERE A PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580972 ↗
• MalfunctionJan 5, 2024Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT, THE SINGLE USE INJECTOR, WHEN ATTEMPTING TO INJECT EPINEPHRINE, IT WAS NOT POSSIBLE DUE TO BLOCKAGE. THE ISSUE WAS FOUND DURING THE PROCEDURE. THE PROCEDURE WAS THERAPEUTIC. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18456112 ↗
• MalfunctionJun 5, 2023Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT HIS OLYMPUS SINGLE-USE INJECTOR WAS EXPERIENCING REMOVAL DIFFICULTY DURING A COLON TATTOOING FOR A SURGICAL RESECTION. ACCORDING TO THE INITIAL REPORTER, THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED. HOWEVER, DURING THE PROCEDURE, WHILE THE INJECTOR WAS INSIDE THE SCOPE, THE NURSE INJECTED THE COLOR DYE AND THE SOLUTION GOT STUCK AND COULD NOT FLOW THROUGH THE LUMEN. REPORTEDLY, THE NURSE ATTEMPTED SEVERAL TIMES AND EVENTUALLY THE NEEDLE COULD NOT BE RETRACTED AND DEPLOYED. THE PHYSICIAN WAS ULTIMATELY ABLE TO COMPLETE THE PROCEDURE, WITHOUT PATIENT HARM, BY USING ANOTHER INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058694 ↗
• MalfunctionJan 7, 2022Difficult to Insert; Difficult to Insert

  WHEN PERFORMING A THERAPEUTIC INTESTINAL POLYPECTOMY, THE NURSE ATTEMPTED TO PERFORM A SUBMUCOSAL INJECTION USING A SINGLE USE INJECTOR, HOWEVER, THE LIQUID WAS UNABLE TO BE INJECTED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THE CUSTOMER PERFORMED A PRE-USE INSPECTION TO CONFIRM THAT THE DEVICE COULD INJECT A LIQUID BEFORE THE PROCEDURE. THE NEEDLE WAS EXTENDED WITH NO PROBLEM WHEN THE SLIDER WAS PUSHED (DURING PROCEDURE). THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193787 ↗
• MalfunctionSep 8, 2020No Flow; No Flow

  IT WAS REPORTED THAT THE SLIDER OF THE SUBJECT DEVICE COULD NOT BE MOVED FORTH DURING AN INSPECTION BEFORE USE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS (B)(4) FOUND THAT THE NEEDLE COULD BE MOVED BACK AND FORTH, BUT THE LIQUID COULD HARDLY BE INJECTED THROUGH THE NEEDLE. THIS IS THE REPORT REGARDING THE FAILURE OF INJECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501399 ↗