Single Use Injector NM600/610 NM-610U-0325Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Injector NM600/610 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170422799), received between Mar 29, 2024 and Jun 21, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
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
- Failure to Deliver1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE SINGLE USE INJECTOR COULD NOT DELIVER FLUID. THE ISSUE WAS FOUND DURING A THERAPEUTIC LARGE INTESTINE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), WHICH WAS COMPLETED USING A SIMILAR DEVICE. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590313 ↗MalfunctionMar 29, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT WHEN OPENING A NEW PRODUCT OF SINGLE USE INJECTOR NM600/610 FOR USE. THE CUSTOMER TRIED TO FLUSH IT WITH THE SYRINGE, BUT THERE WAS CONSIDERABLE RESISTANCE TO THE SYRINGE. THE SYRINGE WAS REPLACED, AND THE THERAPEUTIC PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19003366 ↗
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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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