Single Use Injector NM600/610 NM-610U-0326Recalls & 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 04953170422805), received between Dec 3, 2023 and Jun 19, 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
- Pumping Problem1
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 19, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED TWO SINGLE USE INJECTORS (NM-610U-0326) COULD NOT DELIVER FLUID. THE DEVICE WAS NOT INSPECTED BEFORE USE. THE PROCEDURE WAS A THERAPEUTIC LARGE INTESTINE ELECTROSTATIC DISCHARGE, WHICH WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19568544 ↗MalfunctionDec 3, 2023Pumping Problem; Pumping Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE-USE INJECTOR BECAME DIFFICULT TO PUMP THE FLUID. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18253688 ↗
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- 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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