Single Use Injector NM600/610 NM-600L-0521Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170377570), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2018Break; Break
DURING A HEMOSTASIS FOR GASTRIC VARICES BLEEDING, THE SUBJECT DEVICE WAS USED. ALTHOUGH THE USER TRIED TO RETRACT THE NEEDLE OF THE SUBJECT DEVICE, THE NEEDLE COULD NOT BE RETRACTED INTO THE TUBE. THE USER REMOVED THE SUBJECT DEVICE AND ENDOSCOPE FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED. THIS IS THE REPORT REGARDING THE INABILITY TO RETRACT THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7976997 ↗
Other endoscopic injection needle, gastroenterology-urology devices
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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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