Single Use Injector NM600/610 NM-600L-0621Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170377594), received between Feb 2, 2023 and Feb 2, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Laceration(s)1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROCEDURE-RELATED COMPLICATIONS IN GASTRIC VARICEAL OBTURATION WITH TISSUE GLUE". THE AIM OF THIS ARTICLE WAS TO FOCUS ON PROCEDURE-RELATED COMPLICATIONS, EVALUATE THEIR INCIDENCE, ANALYZE THE REASONS AND DISCUSS THE SOLUTIONS IN 519 PATIENTS. COMPLICATIONS INCLUDING STICKING OF THE NEEDLE TO THE VARIX OCCURRED IN 9 CASES (1.43%). THE NEEDLE WAS SUCCESSFULLY WITHDRAWN IN 8 CASES. LARGE SPURT BLEEDING OCCURRED IN ONE CASE, AND HEMOSTASIS WAS ACHIEVED BY TWO OTHER INJECTIONS OF UNDILUTED GLUE. THE INJECTION CATHETER BECAME BLOCKED IN 17 CASES (2.71%) JUST DURING THE INJECTION, AND 4 CASES WERE COMPLICATED WITH THE NEEDLE STICKING TO THE VARIX. LARGE GLUE ADHESION TO THE ENDOSCOPE RESULTED IN DIFFICULTY WITHDRAWING THE ENDOSCOPE IN 1 CASE. THIS STUDY CONCLUDES THAT EGVO WITH TISSUE GLUE IS USUALLY SAFE AND EFFECTIVE, A SERIES OF COMPLICATIONS CAN OCCUR DURING THE PROCEDURE THAT MAY PUZZLE ENDOSCOPISTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. STICKING OF THE NEEDLE TO THE VARIX - 9 PATIENTS. BLOCKAGE OF THE INJECTION CATHETER - 17 PATIENTS. GLUE ADHESION TO THE ENDOSCOPE RESULTED IN DIFFICULTY WITHDRAWING THE ENDOSCOPE - 1 PATIENT. L
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Unspecified Tissue Injury
MAUDE report 16288203 ↗
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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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