Single Use Injector NM-401L-0423 (UDI 04953170382338)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170382338), received between Apr 15, 2021 and Nov 3, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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.

• MalfunctionNov 3, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO INJECTION NEEDLES MALFUNCTION DURING A PROCEDURE WHEN USED WITH A NASAL SCOPE. THE TWO NEEDLES WERE TESTED DURING THE SCOPY AND IT WAS NOT POSSIBLE TO INSERT THE MEDICATION AS INTENDED. THE NEEDLES WERE TESTED WITH DIFFERENT AGENTS INCLUDING WATER AND IT WAS NOT POSSIBLE TO GET ANYTHING OUT OF THE NEEDLES AND ALSO TESTED WITH HIGH PRESSURE SYRINGES OUTSIDE THE SCOPE. THE CUSTOMER ADDED THAT THE PROCEDURE WAS INTENDED TO INJECT STEROIDS COMBINED WITH DILATION IN ESOPHAGUS ON A CHILD. THE NEEDLE WAS TESTED BEFORE IT WAS ADVANCED IN THE WORKING CHANNEL OF A NASAL SCOPE. THE CUSTOMER WASN'T ABLE TO INJECT AND THEN EXPERIENCED A PAUSE. ALSO, DIFFERENT SYRINGES WERE TRIED BUT NONE WORKED AND ANOTHER NEEDLE WAS TRIED BUT AN UNSUCCESSFUL ATTEMPT. THE CUSTOMER INDICATED THAT THEY WERE ABLE TO PERFORM DILATATION. NO HARM WAS DONE TO THE PATIENT. THE PROCEDURE (BLOCKING WAS PERFORMED WITHOUT MEDICAL INJECTION FOR STEROIDS). NO INTERVENTION WAS PERFORMED. THE PROCEDURE WAS THUS CANCELLED FOR INJECTING STEROIDS. THE PROCEDURE WAS COMPLETED THE SAME DAY. THE PROCEDURE WAS TO DO BOTH BLOCKING IN ESOPHAGUS AND INJECT MEDICINE/TRIAMCINOLONE, DUE TO ESOPHAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595724 ↗
• MalfunctionNov 1, 2024Failure to Eject; Failure to Eject

  IT WAS REPORTED, THE SINGLE USE INJECTOR DID NOT WORK, DURING A PROCEDURE LAST WEEK. IT WAS NOT POSSIBLE, TO INSERT THE AGENT. IT WAS TESTED WITH DIFFERENT AGENTS, INCLUDING WATER, BUT IT WAS NOT POSSIBLE TO GET ANYTHING OUT OF THE NEEDLE. IT WAS ALSO, TESTED WITH HIGH-PRESSURE SYRINGES AND OUTSIDE THE SCOPE. THE ISSUE OCCURRED, DURING AN ESOPHAGEAL STRICTURE PROCEDURE. THERE WAS NO DELAY. AND THE PROCEDURE WAS COMPLETED WITHOUT THE INJECTION. THE PRODUCT WAS INSPECTED BEFORE THE PROCEDURE AND THERE WAS NO ABNORMALITY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20592148 ↗
• MalfunctionFeb 28, 2023Mechanical Problem; Failure to Deliver; Infusion or Flow Problem; Mechanical Problem; Failure to Deliver; Infusion or Flow Problem

  THE CUSTOMER INFORMED THE NORWEGIAN MEDICINES AGENCY ABOUT THE INCIDENT. THE NORWEGIAN MEDICINES AGENCY CONTACTED OLYMPUS ABOUT THE COMPLAINT. COMPLAINT REPORTED NOTED "UNABLE TO INJECT LIQUID INTO THE TARGET TISSUE." THE ISSUE FOUND DURING AN UNSPECIFIED PROCEDURE. NO HARM WAS REPORTED. NO PATIENT HARM, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454404 ↗
• MalfunctionNov 18, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS, THE SINGLE USE INJECTOR COULD NOT DELIVER THE LIQUID TO THE TARGET TISSUE DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING WITH A SIMILAR PRODUCT AND THERE WAS NO DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826051 ↗
• MalfunctionApr 27, 2021Infusion or Flow Problem; Infusion or Flow Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING A PROCEDURE OF VOCAL FOLD AUGMENTATION USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE DEVICE WAS USED FOR THE APPLICATION OF RESTYLANE VITAL LIGHT SKINBOOSTER WHICH HAD A GEL-LIKE CONSISTENCY. THIS AGENT WAS INJECTED INTO THE VOCAL CORDS BY THE DEVICE VIA THE ENDOSCOPE. THE AGENT WAS NOT THE ENTIRE INTENDED AMOUNT WAS INJECTED, BUT WAS AT LEAST A SATISFACTORY AMOUNT. AFTER THE NEEDLE WAS STUCK AND IT WAS NOT POSSIBLE TO INJECT THE AGENT. THE DEVICE CAN NO LONGER BE RETRACTED INTO THE SHEATH AND THE AGENT WAS SPRAYED OUT FROM THE HANDLE. THE SAME PRODUCT WAS USED TO ATTEMPT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE MULTIPLE ATTEMPTS TO INSERT THE NEEDLE THROUGH THE ENDOSCOPE SIGNIFICANTLY PROLONGED THE OUTPATIENT PROCEDURE AND RESULTED IN SIGNIFICANTLY MORE GAGGING FOR THE PATIENT DUE TO THE BRONCHOSCOPIC MANIPULATIONS. HOWEVER, NO SERIOUS DETERIORATION OF THE PATIENT OCCURRED. THE DEVICE WAS NOT DAMAGED.

  Patient problems: Nausea

  MAUDE report 11730456 ↗
• MalfunctionApr 16, 2021Infusion or Flow Problem; Infusion or Flow Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE FOLLOWING REPORT. DURING THE ENT PROCEDURE, TWO DEVICES WERE USED FOR BOTOX INJECTION INTO THE LARYNX. ACCORDING TO THE CUSTOMER, ALL OF THE INJECTION NEEDLES IN THE BOX MALFUNCTIONED. THE NEEDLE WAS PREFILLED WITH BOTOX BEFORE INTRODUCED THROUGH THE WORKING CHANNEL. WHEN EXTENDING THE NEEDLE FROM THE SHEATH, FLUID COULD NOT BE INJECTED (NO FLOW). HOWEVER, WHEN RETRACTING THE NEEDLE INTO THE SHEATH, FLUID COULD BE INJECTED/FLUSHED (FLOW). THIS PROBLEM DID NOT OCCUR WHEN SELECTING NEEDLES FROM ANOTHER BOX. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE SECOND OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676608 ↗
• MalfunctionApr 15, 2021Infusion or Flow Problem; Infusion or Flow Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE FOLLOWING REPORT. DURING THE ENT PROCEDURE, TWO DEVICES WERE USED FOR BOTOX INJECTION INTO THE LARYNX. ACCORDING TO THE CUSTOMER, ALL OF THE INJECTION NEEDLES IN THE BOX MALFUNCTIONED. THE NEEDLE WAS PREFILLED WITH BOTOX BEFORE INTRODUCED THROUGH THE WORKING CHANNEL. WHEN EXTENDING THE NEEDLE FROM THE SHEATH, FLUID COULD NOT BE INJECTED (NO FLOW). HOWEVER, WHEN RETRACTING THE NEEDLE INTO THE SHEATH, FLUID COULD BE INJECTED/FLUSHED (FLOW). THIS PROBLEM DID NOT OCCUR WHEN SELECTING NEEDLES FROM ANOTHER BOX. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE FIRST OF TWO DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676405 ↗