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Single Use Injector NM-401L-0523 (UDI 04953170382352)Recalls & reported problems

Olympus Medical Systems Corp. · Class 2

All models of Single Use Injector (29)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170382352), received between Jul 17, 2020 and Oct 9, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Flow” (5 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

Device problems

  • No Flow5

Patient problems

  • No Consequences Or Impact To Patient5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 9, 2020No Flow; No Flow

    DURING AN UNSPECIFIED PROCEDURE, TWO DEVICES WERE USED. THE NEEDLE WAS BLOCKED AND THE SOLUTION COULD NOT BE INJECTED ON BOTH DEVICES. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE SECOND ONE OF TWO REPORTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10654352 ↗
  • MalfunctionOct 9, 2020No Flow; No Flow

    DURING AN UNSPECIFIED PROCEDURE, TWO DEVICES WERE USED. THE NEEDLE WAS BLOCKED AND THE SOLUTION COULD NOT BE INJECTED ON BOTH DEVICES. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE FIRST ONE OF TWO REPORTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10654332 ↗
  • MalfunctionJul 20, 2020No Flow; No Flow

    DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE NEEDLE COULD NOT BE EXTENDED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 3, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE SUBJECT DEVICE COULD NOT PERFORM THE INJECTION. THIS IS THE REPORT REGARDING THE FAILURE OF INJECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10294129 ↗
  • MalfunctionJul 20, 2020No Flow; No Flow

    DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE NEEDLE COULD NOT BE EXTENDED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 3, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE SUBJECT DEVICE COULD NOT PERFORM THE INJECTION. THIS IS THE REPORT REGARDING THE FAILURE OF INJECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10294120 ↗
  • MalfunctionJul 17, 2020No Flow; No Flow

    DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. THE NEEDLE COULD NOT BE EXTENDED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON JULY 3, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE SUBJECT DEVICE COULD NOT PERFORM THE INJECTION. THIS IS THE REPORT REGARDING THE FAILURE OF INJECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10287738 ↗

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Sources and updates

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