Single Use Injector NM-400U-0423 (REF N6139630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170422560), received between Feb 22, 2022 and Jun 25, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE SINGLE USE INJECTOR WAS UNABLE TO INJECT FLUID TO TARGET TISSUES. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610282 ↗
• MalfunctionJun 21, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE SINGLE USE INJECTOR COULD INJECT FLUID. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583198 ↗
• MalfunctionNov 16, 2023Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE INJECTOR LIQUID IS HARD TO BE INJECTED OUT THE NEEDLES. THE USER FINISHED THE CASE WITH ANOTHER SIMILAR DEVICE. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148769 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: ¿NOVEL ENDOSCOPIC TREATMENT STRATEGY FOR EARLY ESOPHAGEAL CANCER IN CIRRHOTIC PATIENTS WITH ESOPHAGEAL VARICES,¿ THREE PATIENTS EXPERIENCED LARGE BLEEDING DURING ENDOSCOPIC MUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 5 OF 6. STUDY AIM: ESTABLISH A STANDARD T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14143201 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: ¿NOVEL ENDOSCOPIC TREATMENT STRATEGY FOR EARLY ESOPHAGEAL CANCER IN CIRRHOTIC PATIENTS WITH ESOPHAGEAL VARICES,¿ THREE PATIENTS EXPERIENCED LARGE BLEEDING DURING ENDOSCOPIC MUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 5 OF 6. STUDY AIM: ESTABLISH A STANDARD T

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14142994 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED: ¿NOVEL ENDOSCOPIC TREATMENT STRATEGY FOR EARLY ESOPHAGEAL CANCER IN CIRRHOTIC PATIENTS WITH ESOPHAGEAL VARICES,¿ THREE PATIENTS EXPERIENCED LARGE BLEEDING DURING ENDOSCOPIC MUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE5 OF 6. STUDY AIM: ESTABLISH A STANDARD TR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14142943 ↗
• MalfunctionFeb 22, 2022No Flow; No Flow

  AS REPORTED DURING AN ENDOSCOPY THERAPEUTIC POLIPECTOMY PROCEDURE, THE NURSE OPENED AND INSERTED THE DEVICE INTO THE INSTRUMENT CHANNEL AND WHEN TRIED TO USE IT, THE INJECTOR WAS NOT PERMEABLE. THE DEVICE WAS REPLACED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582184 ↗