Single Use Injector NM600/610 NM-610U-0423 (REF N6142330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170422836), received between Nov 4, 2023 and Feb 12, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Infuse” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "RISK FACTORS FOR PERFORATION DURING COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION." ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ACHIEVES HIGHER EN BLOC RESECTION RATES THAN ENDOSCOPIC MUCOSAL RESECTION IN EARLY COLORECTAL NEOPLASMS. HOWEVER, PERFORATION OCCURS MORE FREQUENTLY DURING ESD. WE AIMED TO IDENTIFY THE RISK FACTORS FOR PERFORATION DURING COLORECTAL ESD. A TOTAL OF 161 PATIENTS TREATED WITH COLORECTAL ESD AT A TERTIARY CENTER BETWEEN JANUARY 2014 AND DECEMBER 2019 WERE ENROLLED IN THIS RETROSPECTIVE STUDY. PERFORATION WAS DEFINED AS A DEEP DEFECT OF THE MUSCULARIS PROPRIA, WITH OR WITHOUT DIRECT CONTACT WITH CONNECTIVE TISSUE OUTSIDE THE COLON. CLINICAL RISK FACTORS FOR PERFORATION DURING ESD, INCLUDING AGE, SEX, TUMOR MORPHOLOGY, TUMOR SIZE, TUMOR LOCATION, PROCEDURE TIME, EN BLOC RESECTION RATE, HISTOLOGY, AND SUBMUCOSAL FIBROSIS, WERE ANALYZED. THE MEAN SIZE OF THE ESD SPECIMENS WAS 38.2 ± 24.6 MM. THE OVERALL EN BLOC RESECTION RATE WAS 98.1%. PERFORATIONS OCCURRED DURING ESD IN 31 OUT OF 161 PATIENTS (19.3%). ALL PERFORATIONS WERE SUCCESSFULLY TREATED WITH ENDOSCOPIC CLOSURE USING THE HEMOCLIPS AND NONSURGICAL MANAGEMENT. EMERGENCY SURG

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18684848 ↗
• MalfunctionNov 4, 2023Failure to Infuse; Failure to Infuse

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN THE SINGLE USE INJECTOR NEEDLE WAS PUSHED OUT, THE LOCK ON THE HAND SIDE DID NOT CLICK INTO PLACE. AFTER THAT, WHEN THE CLINICIAN PASSED IT THROUGH AN ENDOSCOPE AND TRIED TO GET THE FLUID AND NEEDLE OUT, THE CLINICIAN COULD NOT SEND THE FLUID, AND THE NEEDLE DID NOT COME OUT EITHER. THE ISSUE WAS FOUND DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, WHICH WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070236 ↗