Single Use Injector NM-401L-0623 (REF N6140630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04953170422669), received between Jul 12, 2021 and Jun 28, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Failure to Prime; Difficult to Advance; Failure to Prime; Difficult to Advance

  IT WAS REPORTED, THE INJECTOR AND SHEATH SET WAS UNABLE TO INJECT KENAKORT VIA THE NASAL DEVICE AFTER BOUGIENAGE USING A SCLERAL NEEDLE. THE NEEDLE WAS DEFLATED OUTSIDE THE BODY WITH THE NEEDLE RETRACTED AND THEN HANDED TO THE DOCTOR. WHEN AN ATTEMPT WAS MADE INSIDE THE BODY TO INJECT THE KENAKORT WITH AN OPEN NEEDLE, THIS COULD NOT BE DONE AS THERE WAS A GREAT DEAL OF RESISTANCE AND NOTHING COULD BE INJECTED. THE NEEDLE WAS CHANGED AND THE SAME PROBLEM OCCURRED WITH THE SECOND NEEDLE. BOTH NEEDLES WERE ALSO TRIED OUTSIDE THE BODY. INJECTION WORKED WITH THE NEEDLE RETRACTED, BUT NOT WITH THE NEEDLE EXTENDED. THERE WAS A MAJOR TIME DELAY AND THE WHOLE DEVICE HAD TO BE CHANGED AND THEN A NORMAL SCLEROSING NEEDLE HAD TO BE TAKEN. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT. THERE IS NO INDICATION THAT THE DELAY WAS OVER 30 MINUTES OR THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE ISSUE OCCURRED DURING A THERAPEUTIC NASAL KENAKORT INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634148 ↗
• MalfunctionJun 28, 2024Difficult to Insert; Failure to Prime; Difficult to Insert; Failure to Prime

  IT WAS REPORTED, THE INJECTOR AND SHEATH SET WAS UNABLE TO INJECT KENAKORT VIA THE NASAL DEVICE AFTER BOUGIENAGE USING A SCLERAL NEEDLE. THE NEEDLE WAS DEFLATED OUTSIDE THE BODY WITH THE NEEDLE RETRACTED AND THEN HANDED TO THE DOCTOR. WHEN AN ATTEMPT WAS MADE INSIDE THE BODY TO INJECT THE KENAKORT WITH AN OPEN NEEDLE, THIS COULD NOT BE DONE AS THERE WAS A GREAT DEAL OF RESISTANCE AND NOTHING COULD BE INJECTED. THE NEEDLE WAS CHANGED AND THE SAME PROBLEM OCCURRED WITH THE SECOND NEEDLE. BOTH NEEDLES WERE ALSO TRIED OUTSIDE THE BODY. INJECTION WORKED WITH THE NEEDLE RETRACTED, BUT NOT WITH THE NEEDLE EXTENDED. THERE WAS A MAJOR TIME DELAY AND THE WHOLE DEVICE HAD TO BE CHANGED AND THEN A NORMAL SCLEROSING NEEDLE HAD TO BE TAKEN. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT. THERE IS NO INDICATION THAT THE DELAY WAS OVER 30 MINUTES OR THAT THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE ISSUE OCCURRED DURING A THERAPEUTIC NASAL KENAKORT INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633955 ↗
• MalfunctionDec 29, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED TO OLYMPUS THAT THE SINGLE USE INJECTOR NEEDLE GOT BENT DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION WHICH STOPPED THE FLOW. THE NEEDLE HAD TO INJECTED REPEATEDLY WHICH LED TO THE NEEDLE BEING BENT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074261 ↗
• MalfunctionDec 29, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE NEEDLE WOULD ULTIMATELY NOT INJECT, EVEN WHEN MULTIPLE ATTEMPTS WERE MADE TO INJECT USING THE DEVICE. THE CUSTOMER NOTED THAT THE NEEDLE BENT, WHICH PREVENTED THE INTENDED FLOW AND INHIBITED THE INTENDED USE OF THE DEVICE. THE NEEDLE HAD TO BE REPLACED AT LEAST 5 TIMES IN THE SAME PROCEDURE DUE TO THIS ISSUE. EVENTUALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE PROCEDURE WAS LENGTHENED BY AN UNSPECIFIED AMOUNT OF TIME DUE TO THE PRODUCT PROBLEMS, THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068661 ↗
• MalfunctionDec 29, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE NEEDLE WOULD ULTIMATELY NOT INJECT, EVEN WHEN MULTIPLE ATTEMPTS WERE MADE TO INJECT USING THE DEVICE. THE CUSTOMER NOTED THAT THE NEEDLE BENT, WHICH PREVENTED THE INTENDED FLOW AND INHIBITED THE INTENDED USE OF THE DEVICE. THE NEEDLE HAD TO BE REPLACED AT LEAST 5 TIMES IN THE SAME PROCEDURE DUE TO THIS ISSUE. EVENTUALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE PROCEDURE WAS LENGTHENED BY AN UNSPECIFIED AMOUNT OF TIME DUE TO THE PRODUCT PROBLEMS, THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068439 ↗
• MalfunctionDec 29, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE NEEDLE WOULD ULTIMATELY NOT INJECT, EVEN WHEN MULTIPLE ATTEMPTS WERE MADE TO INJECT USING THE DEVICE. THE CUSTOMER NOTED THAT THE NEEDLE BENT, WHICH PREVENTED THE INTENDED FLOW AND INHIBITED THE INTENDED USE OF THE DEVICE. THE NEEDLE HAD TO BE REPLACED AT LEAST 5 TIMES IN THE SAME PROCEDURE DUE TO THIS ISSUE. EVENTUALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE PROCEDURE WAS LENGTHENED BY AN UNSPECIFIED AMOUNT OF TIME DUE TO THE PRODUCT PROBLEMS, THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068251 ↗
• MalfunctionDec 29, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE NEEDLE WOULD ULTIMATELY NOT INJECT, EVEN WHEN MULTIPLE ATTEMPTS WERE MADE TO INJECT USING THE DEVICE. THE CUSTOMER NOTED THAT THE NEEDLE BENT, WHICH PREVENTED THE INTENDED FLOW AND INHIBITED THE INTENDED USE OF THE DEVICE. THE NEEDLE HAD TO BE REPLACED AT LEAST 5 TIMES IN THE SAME PROCEDURE DUE TO THIS ISSUE. EVENTUALLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE PROCEDURE WAS LENGTHENED BY AN UNSPECIFIED AMOUNT OF TIME DUE TO THE PRODUCT PROBLEMS, THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067903 ↗
• MalfunctionDec 16, 2022Failure to Deliver; Failure to Deliver

  THE CUSTOMER REPORTED TO OLYMPUS THAT, DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE NEEDLE WOULD ULTIMATELY NOT INJECT. MULTIPLE ATTEMPTS WERE MADE TO INJECT USING THE DEVICE. THE NEEDLE HAD TO BE REPLACED AT LEAST 5 TIMES IN THE SAME PROCEDURE DUE TO THIS ISSUE. ALTHOUGH THE PROCEDURE WAS LENGTHENED BY AN UNSPECIFIED AMOUNT OF TIME, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999822 ↗
• MalfunctionJul 25, 2022Mechanical Problem; No Flow; Mechanical Problem; No Flow

  AS REPORTED, A PROBLEM HAS OCCURRED WITH THE SAMPLE PRODUCT (DEMO PRODUCT). THE DOCTOR INSERTED IT INTO THE FORCEPS CHANNEL AND TRIED TO INJECT THE DRUG SOLUTION (KENACORT) LOCALLY, BUT THE INJECTION AMOUNT WAS TOO HEAVY TO INJECT. USER TRIED TO SEE IF THE DRUG SOLUTION CAME OUT EVEN OUTSIDE THE BODY CAVITY BUT IT DID NOT. THE DEVICE WAS REPLACED. THE INTENDED PROCEDURE (VOCAL CORD STEROID INJECTION (THERAPEUTIC) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. ACCORDING TO THE REPORTER, THE DEVICE WAS INSPECTED PRIOR TO USE, NO PROBLEM FOUND DURING THE PREOPERATIVE INJECTION CHECK. THIS REPORT IS BEING SUBMITTED FOR INJECTION NEEDLE MALFUNCTIONS, PROBLEM OF PUNCTURE / PROBLEMS OF DELIVERING LIQUID. UNABLE TO INJECT LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15095283 ↗
• MalfunctionDec 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, IN THE BEGINNING OF THE PROCEDURE, AFTER THE INJECTOR FORCE MAX NEEDLE WAS PRIMED WITH THE SOLUTION, THE SOLUTION WOULD NOT FLOW THROUGH THE NEEDLE TIP AFTER IT WAS EXTENDED PASSED THE SHEATH. THERE WAS NO PATIENT INJURY OR HARM REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003779 ↗
• MalfunctionDec 14, 2021Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED, IN THE BEGINNING OF THE PROCEDURE, AFTER THE INJECTOR FORCE MAX NEEDLE WAS PRIMED WITH THE SOLUTION, THE SOLUTION WOULD NOT FLOW THROUGH THE NEEDLE TIP AFTER IT WAS EXTENDED PAST THE SHEATH. THERE WAS NO PATIENT INJURY OR HARM REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003254 ↗
• MalfunctionSep 28, 2021Defective Device; Defective Device

  UPDATES ON EVENT REPORTED. TWO NEEDLES FAILED DURING THE PROCEDURE. THE THIRD NEEDLE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544521 ↗
• MalfunctionSep 28, 2021Defective Device; Defective Device

  UPDATES ON EVENT REPORTED. TWO NEEDLES FAILED DURING THE PROCEDURE. THE THIRD NEEDLE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544422 ↗
• MalfunctionSep 28, 2021Defective Device; Defective Device

  AS REPORTED, THE CUSTOMER HAVE EXPERIENCED 3 (THREE) INJECTORFORCEMAX MODEL NO. NM-401L-0623 NEEDLE FAILURES. THE SAME SCENARIO, WHEN THE NEEDLE IS EXTENDED OUTSIDE THE SHAFT UNABLE TO INJECT THE FLUID. THE INITIAL PRIME OF THE NEEDLE IS FINE. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THE CUSTOMER STATED THE FIRST 3 NEEDLES THAT WAS USED HAD THE SAME ISSUE AND DID NOT WORKED. THE FOURTH NEEDLE FROM THE SAME BOX WORKED AS EXPECTED AND THE INTENDED PROCEDURE WAS COMPLETED WITH NO HARM OR INJURY TO THE PATIENT. THERE WAS NO USER INJURY REPORTED. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF THE NEEDLE USED TO COMPLETE THE PROCEDURE. THIS REPORT IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544318 ↗
• MalfunctionAug 18, 2021Filling Problem; Defective Device; Filling Problem; Defective Device

  IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR A THERAPEUTIC STEROID INJECTION TO SUBGLOTTIC STENOSIS PROCEDURE, THE DEVICE HAD AN ISSUE DURING PRIMING. THE DEVICE WAS REPLACED WITH SIMILAR DEVICE FROM THE SAME BOX AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE THIS EVENT. NO USER INJURY REPORTED. THIS EVENT REPORTED IS RELATED TO REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340237 ↗
• MalfunctionJul 12, 2021Filling Problem; Defective Device; Filling Problem; Defective Device

  IT WAS REPORTED THAT DURING A THERAPEUTIC PROCEDURE, THE CUSTOMER WAS UNABLE TO INJECT SOLUTION WHEN THE NEEDLE WAS EXTENDED PASS THE SHEATHS. THE INTENDED PROCEDURE WAS COMPLETED WITH SAME SIMILAR NEEDLES FROM THE SAME BOX. THERE WAS NO PATIENT HARM OR IMPACT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12153487 ↗