Single Use Injector NM-400U-0425 (UDI 04953170259937)Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Injector · Class 2
All models of Single Use Injector (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170259937), received between Nov 8, 2023 and Oct 4, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Difficult to Insert1
- Infusion or Flow Problem1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2024Break; Break
IT WAS REPORTED THAT THE INJECTOR NEEDLE WAS HARD TO OPEN AND CLOSE. FURTHER, THE NEEDLE WAS BROKEN INSIDE THE PATIENT IN AN UNSPECIFIED CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 20371493 ↗InjurySep 30, 2024Break; Difficult to Insert; Break; Difficult to Insert
IT WAS NOTED THAT THE INJECTOR NEEDLE WAS BROKEN INSIDE THE PATIENT IN AN UNSPECIFIED CASE. THERE IS NO FURTHER INFORMATION RECEIVED AT THIS TIME.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20340511 ↗MalfunctionNov 8, 2023Infusion or Flow Problem; Infusion or Flow Problem
A CUSTOMER REPORTED TO OLYMPUS, WHEN THE INJECTOR (NEEDLE) WAS USED TO INJECT, IT WAS ABNORMAL DUE TO CLOGGING. THE THERAPEUTIC COLON POLYPECTOMY WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR HEALTH DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18097851 ↗
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- injeTAK Adjustable Tip Needle 70cm DIS201Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- injeTAK Adjustable Tip Needle 35cm DIS199Laborie Medical Technologies Canada ULC · endoscopic injection needle, gastroenterology-urology1 recall0 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology28 reports
- Single Use Injector NM-401L-0423Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology27 reports
- Single Use Injector NM-401L-0425Olympus Medical Systems Corp. · endoscopic injection needle, gastroenterology-urology26 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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