Single Use Injector NM600/610 NM-610L-0423Recalls & 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
- 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 04953170422829), received between May 10, 2022 and May 10, 2022 — 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
- Perforation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE FOR DUODENAL NEUROENDOCRINE TUMORS". LITERATURE SUMMARY: THIS STUDY EXAMINED THE TREATMENT RESULTS OF ENDOSCOPIC MUCOSAL RESECTION WITH A LIGATION DEVICE (EMR-L) FOR THE REMOVAL OF DUODENAL NETS LOCATED IN THE SUBMUCOSAL LAYER WITHOUT METASTASIS. EMR-L CAN BE PERFORMED WITH LESS TECHNICAL SKILL, AND THE LIGATION DEVICE REDUCES THE RATE OF POSITIVE VERTICAL MARGIN. THE EN BLOC RESECTION RATE AND ENDOSCOPIC COMPLETE RESECTION RATE WERE BOTH (B)(4). COMPLETE RESECTION WAS ACHIEVED PATHOLOGICALLY IN 7 LESIONS ((B)(4)). THE VERTICAL MARGINS WERE NEGATIVE IN ALL CASES. LYMPHATIC VESSEL INVASION WAS OBSERVED IN THREE PATIENTS, ALL OF WHOM UNDERWENT ADDITIONAL SURGERY WITH LYMPH NODE DISSECTION (ONE OF THEM ALSO EXHIBITED BLOOD VESSEL INVASION AND A POSITIVE HORIZONTAL MARGIN). NO EVIDENCE OF RESIDUAL TUMORS OR LYMPH NODE METASTASIS WAS OBSERVED IN ANY OF THE PATIENTS. NO RECURRENCE WAS OBSERVED IN ANY OF THE 10 PATIENTS (MEAN FOLLOW-UP PERIOD: 18.6 MONTHS). ONE PATIENT ((B)(4)) EXPERIENCED INTRAOPERATIVE BLEEDING. PERFORATION OCCURRED IN 1 PATIENT ((B)(4)), BUT THE CO
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation
MAUDE report 14346455 ↗
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- 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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