Single Use Injector NM-401L-0425 (UDI 04953170260070)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170260070), received between Jun 10, 2019 and Apr 6, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “No Flow” (8 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Failure to Deliver

  IT WAS REPORTED THE SINGLE-USE INJECTOR WAS UNABLE TO INJECT BOTOX WHEN THE NEEDLE WAS FULLY EXTENDED. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794074 ↗
• MalfunctionNov 11, 2024Blocked Connection; Blocked Connection

  IT WAS REPORTED, THE SINGLE USE INJECTOR NEEDLE GOT BLOCKED, DURING INJECTION. UNABLE TO PUNCTURE. THE ISSUE OCCURRED, DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652872 ↗
• MalfunctionJul 3, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED, THE SINGLE USE INJECTOR WAS UNABLE TO INJECT BOTOX INTO PATIENT'S PYLORUS. THE ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668411 ↗
• MalfunctionApr 25, 2024Failure to Discharge; Failure to Discharge

  IT WAS REPORTED THE SINGLE USE INJECTOR FAILED TO INJECT WHEN THE NEEDLE WAS DEPLOYED. THE ISSUE OCCURRED DURING THERAPEUTIC SURGERY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180869 ↗
• MalfunctionFeb 7, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR WAS PART OF A PROCEDURE IN WHICH VARIOUS NEEDLES FAILED DURING DIFFERENT PROCEDURES. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE IN WHICH THE NEEDLES WERE PLACED THROUGH THE CHANNELED ENDOSCOPE AND THE ENDOSCOPE WAS PLACED THROUGH THE PATIENT¿S NOSE TO GET TO THEIR THROAT. THE ONLY OTHER DEVICE WAS THE CHANNELED OLYMPUS ENDOSCOPE. THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES. THE PATIENT WAS AWAKE DURING THE EXAM. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. A NEW NEEDLE WAS USED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661009 ↗
• MalfunctionFeb 7, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR WAS PART OF A PROCEDURE IN WHICH VARIOUS NEEDLES FAILED DURING DIFFERENT PROCEDURES. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE IN WHICH THE NEEDLES WERE PLACED THROUGH THE CHANNELED ENDOSCOPE AND THE ENDOSCOPE WAS PLACED THROUGH THE PATIENT¿S NOSE TO GET TO THEIR THROAT. THE ONLY OTHER DEVICE WAS THE CHANNELED OLYMPUS ENDOSCOPE. THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES. THE PATIENT WAS AWAKE DURING THE EXAM. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. A NEW NEEDLE WAS USED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660547 ↗
• MalfunctionFeb 7, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR WAS PART OF A PROCEDURE IN WHICH VARIOUS NEEDLES FAILED DURING DIFFERENT PROCEDURES. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE IN WHICH THE NEEDLES WERE PLACED THROUGH THE CHANNELED ENDOSCOPE AND THE ENDOSCOPE WAS PLACED THROUGH THE PATIENT¿S NOSE TO GET TO THEIR THROAT. THE ONLY OTHER DEVICE WAS THE CHANNELED OLYMPUS ENDOSCOPE. THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES. THE PATIENT WAS AWAKE DURING THE EXAM. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. A NEW NEEDLE WAS USED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660084 ↗
• MalfunctionFeb 7, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR WAS PART OF A PROCEDURE IN WHICH VARIOUS NEEDLES FAILED DURING DIFFERENT PROCEDURES. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE IN WHICH THE NEEDLES WERE PLACED THROUGH THE CHANNELED ENDOSCOPE AND THE ENDOSCOPE WAS PLACED THROUGH THE PATIENT¿S NOSE TO GET TO THEIR THROAT. THE ONLY OTHER DEVICE WAS THE CHANNELED OLYMPUS ENDOSCOPE. THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES. THE PATIENT WAS AWAKE DURING THE EXAM. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. A NEW NEEDLE WAS USED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS:(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659866 ↗
• MalfunctionFeb 6, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE SINGLE USE INJECTOR WAS PART OF A PROCEDURE IN WHICH VARIOUS NEEDLES FAILED DURING DIFFERENT PROCEDURES. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE IN WHICH THE NEEDLES WERE PLACED THROUGH THE CHANNELED ENDOSCOPE AND THE ENDOSCOPE WAS PLACED THROUGH THE PATIENT¿S NOSE TO GET TO THEIR THROAT. THE ONLY OTHER DEVICE WAS THE CHANNELED OLYMPUS ENDOSCOPE. THERE WAS A DELAY OF APPROXIMATELY 5 MINUTES. THE PATIENT WAS AWAKE DURING THE EXAM. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. A NEW NEEDLE WAS USED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655901 ↗
• MalfunctionFeb 4, 2024No Flow; No Flow

  IT WAS REPORTED THE NEEDLE WAS ENGAGED, HOWEVER, SOLUTION WOULD NOT COME OUT OF TIP. THE DEVICE WAS BEING USED FOR VOCAL CORD INJECTIONS. THE CUSTOMER KEPT TRYING DIFFERENT INJECTION NEEDLES UNTIL THEY FOUND ONE THAT WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637672 ↗
• MalfunctionMar 23, 2023Partial Blockage; Partial Blockage

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING PREPARATION FOR USE FOR A VOCAL CORD INJECTION, THE INJECTION NEEDLE WAS CLOGGED, AND THE LIQUID COULD NOT PASS THROUGH THE SINGLE USE INJECTOR. THE THERAPEUTIC PROCEDURE WAS COMPLETED USING A SIMILAR INJECTOR. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16606006 ↗
• MalfunctionJul 7, 2022Failure to Infuse; Failure to Infuse

  OLYMPUS (OAZ) WAS INFORMED BY THE NURSE AT THE USER FACILITY THAT THE SINGLE USE ¿INJECTOR FAILED AGAIN¿ (UNABLE TO PUMP LIQUID) DURING A THERAPEUTIC STEROID INJECTION FOR SUBGLOTTIC STENOSIS WHILE THE PATIENT WAS AWAKE WITH THE SCOPE IN THE NASOPHARYNX. THE NURSE REPORTED 3 NEEDLES FAILED. ONE OF NEEDLES FAILED WHILE INSIDE THE PATIENT ((B)(6)) AND WAS DISCARDED. IT IS BELIEVED TWO FAILED ((B)(6)) WHILE INSPECTING OUTSIDE OF THE PATIENT WHEN THE NEEDLE WAS DEPLOYED (THE FLUID DID FLOW WHEN THE NEEDLE WAS RETRACTED). UPON OPENING A NEW BOX AND CHECKING THE NEEDLE THE STEROID FLOWED AND WERE ABLE TO PROCEED. THE NURSE REPORTED THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. THIS REPORT PATIENT IDENTIFIER (B)(6), IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950056 ↗
• MalfunctionJul 7, 2022Failure to Infuse; Failure to Infuse

  OLYMPUS (OAZ) WAS INFORMED BY THE NURSE AT THE USER FACILITY THAT THE SINGLE USE ¿INJECTOR FAILED AGAIN¿ (UNABLE TO PUMP LIQUID) DURING A THERAPEUTIC STEROID INJECTION FOR SUBGLOTTIC STENOSIS WHILE THE PATIENT WAS AWAKE WITH THE SCOPE IN THE NASOPHARYNX. THE NURSE REPORTED 3 NEEDLES FAILED. ONE OF NEEDLES FAILED WHILE INSIDE THE PATIENT (B)(4) AND WAS DISCARDED. IT IS BELIEVED TWO FAILED (B)(4) WHILE INSPECTING OUTSIDE OF THE PATIENT WHEN THE NEEDLE WAS DEPLOYED (THE FLUID DID FLOW WHEN THE NEEDLE WAS RETRACTED). UPON OPENING A NEW BOX AND CHECKING THE NEEDLE THE STEROID FLOWED AND WERE ABLE TO PROCEED. THE NURSE REPORTED THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. THIS REPORT PATIENT IDENTIFIER (B)(4) IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14949721 ↗
• InjuryJul 7, 2022Failure to Infuse; Material Twisted/Bent; Failure to Infuse; Material Twisted/Bent

  THE CUSTOMER REPORTED AN 'INJECTOR FAILED AGAIN.' IT WAS ALSO REPORTED THE DEVICE WAS USED ON A PATIENT AND THE DETAILS ARE THE SAME TO THE PREVIOUS REPORT FROM MAY 2022 (CASE WITH PATIENT IDENTIFIER (B)(6)) WHERE IT WAS REPORTED THE SUBJECT DEVICE COULD NOT BE DEPLOYED INSIDE THE PATIENT AND THE PATIENT'S TOLERANCE WAS DECREASING RAPIDLY WITH GAGGING AND COUGHING; THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS.

  Patient problems: Cough

  MAUDE report 14944429 ↗
• MalfunctionJun 16, 2022Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED PRODUCT FAILED DURING THE PROCEDURE, WHILE THE PATIENT WAS AWAKE WITH A SCOPE IN THEIR NASOPHARYNX. IT WAS REPORTED DURING A THERAPEUTIC STEROID INJECTION FOR SUBGLOTTIC STENOSIS PROCEDURE, 2 TO 3 NEEDLES FAILED. ACCORDING TO THE REPORTER, ¿ALL DIDN¿T FLOW OUTSIDE OF THE PATIENT WHEN THE NEEDLE WAS DEPLOYED (THE FLUID DID FLOW WHEN THE NEEDLE WAS RETRACTED)¿. ACCORDING TO THE REPORTER NEEDLES WERE IMMEDIATELY DISCARDED, AND ON OPENING A NEW BOX AND CHECKING THE NEEDLE OUTSIDE OF THE PATIENT, THE STEROID FLOWED AND WERE ABLE TO PROCEED, HOWEVER, BY THE TIME THE FOURTH NEEDLE WAS AVAILABLE, THE REPORTER STATED VISIBILITY IN THE PATIENT WAS DIMINISHED DUE TO SECRETIONS. THE PATIENT'S TOLERANCE WAS DECREASING RAPIDLY WITH GAGGING AND COUGHING. ACCORDING TO THE REPORTER, THE INTENDED PROCEDURE WAS COMPLETED. THE REPORTER REPORTED THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. THIS REPORT PATIENT IDENTIFIER (B)(6), IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6), (B)(6) (3 NEEDLES FAILED AND WERE DISCARDED). THE FOURTH (4TH) NEEDLE IS REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714616 ↗
• MalfunctionJun 16, 2022Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED PRODUCT FAILED DURING THE PROCEDURE, WHILE THE PATIENT WAS AWAKE WITH A SCOPE IN THEIR NASOPHARYNX. IT WAS REPORTED DURING A THERAPEUTIC STEROID INJECTION FOR SUBGLOTTIC STENOSIS PROCEDURE, 2 TO 3 NEEDLES FAILED. ACCORDING TO THE REPORTER, ¿ALL DIDN¿T FLOW OUTSIDE OF THE PATIENT WHEN THE NEEDLE WAS DEPLOYED (THE FLUID DID FLOW WHEN THE NEEDLE WAS RETRACTED).¿ ACCORDING TO THE REPORTER NEEDLES WERE IMMEDIATELY DISCARDED, AND ON OPENING A NEW BOX AND CHECKING THE NEEDLE OUTSIDE OF THE PATIENT, THE STEROID FLOWED AND WERE ABLE TO PROCEED, HOWEVER, BY THE TIME THE FOURTH NEEDLE WAS AVAILABLE, THE REPORTER STATED VISIBILITY IN THE PATIENT WAS DIMINISHED DUE TO SECRETIONS. THE PATIENT'S TOLERANCE WAS DECREASING RAPIDLY WITH GAGGING AND COUGHING. ACCORDING TO THE REPORTER, THE INTENDED PROCEDURE WAS COMPLETED. THE REPORTER REPORTED THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. THIS REPORT PATIENT IDENTIFIER (B)(6) , IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6) AND (B)(6) (3 NEEDLES FAILED AND WERE DISCARDED). THE FOURTH (4TH) NEEDLE IS REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714512 ↗
• MalfunctionJun 16, 2022Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED PRODUCT FAILED DURING THE PROCEDURE, WHILE THE PATIENT WAS AWAKE WITH A SCOPE IN THEIR NASOPHARYNX. IT WAS REPORTED DURING A THERAPEUTIC STEROID INJECTION FOR SUBGLOTTIC STENOSIS PROCEDURE, 2 TO 3 NEEDLES FAILED. ACCORDING TO THE REPORTER, ¿ALL DIDN¿T FLOW OUTSIDE OF THE PATIENT WHEN THE NEEDLE WAS DEPLOYED (THE FLUID DID FLOW WHEN THE NEEDLE WAS RETRACTED).¿ ACCORDING TO THE REPORTER NEEDLES WERE IMMEDIATELY DISCARDED, AND ON OPENING A NEW BOX AND CHECKING THE NEEDLE OUTSIDE OF THE PATIENT, THE STEROID FLOWED AND WERE ABLE TO PROCEED, HOWEVER, BY THE TIME THE FOURTH NEEDLE WAS AVAILABLE, THE REPORTER STATED VISIBILITY IN THE PATIENT WAS DIMINISHED DUE TO SECRETIONS. THE PATIENT'S TOLERANCE WAS DECREASING RAPIDLY WITH GAGGING AND COUGHING. ACCORDING TO THE REPORTER, THE INTENDED PROCEDURE WAS COMPLETED. THE REPORTER REPORTED THE INTENDED PROCEDURE WAS COMPLETED WITH NO ADDITIONAL TREATMENT. THIS REPORT PATIENT IDENTIFIER (B)(6), IS RELATED TO REPORTS WITH PATIENT IDENTIFIER (B)(6), (B)(6) (3 NEEDLES FAILED AND WERE DISCARDED) THE FOURTH (4TH) NEEDLE IS REPORTED UNDER PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14714430 ↗
• InjuryJun 16, 2022Failure to Infuse; Failure to Infuse

  THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR A THERAPEUTIC STEROID INJECTION FOR SUBGLOTTIC STENOSIS PROCEDURE, MULTIPLE DEVICES FAILED AND THE FLUID DID NOT FLOW OUT THE NEEDLE WHEN DEPLOYED OUTSIDE OF THE PATIENT WITH THE INJECTOR IN IT'S RESTING COILED POSITION. THESE EVENTS WILL BE SUBMITTED SEPARATELY. THE CUSTOMER ALSO REPORTED, THE FOURTH SUBJECT DEVICE FAILED DURING AN UNSPECIFIED PROCEDURE WHILE THE PATIENT WAS AWAKE WITH THE ENDOSCOPE IN THEIR NASOPHARYNX. THE SUBJECT DEVICE WAS TESTED PRIOR TO USE AND THERE WERE NO ISSUES. THE CUSTOMER ALSO REPORTED VISIBILITY IN THE PATIENT WAS DIMINISHED DUE TO SECRETIONS. THE PATIENT'S TOLERANCE WAS DECREASING RAPIDLY WITH GAGGING AND COUGHING AND THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. THIS EVENT INCLUDES 4 REPORTS: (B)(6): FOR DEVICE FAILURE INSIDE PATIENT. (B)(6): FOR DEVICE FAILURE BEFORE USE WITH PATIENT. (B)(6): FOR DEVICE FAILURE BEFORE USE WITH PATIENT. (B)(6): FOR DEVICE FAILURE BEFORE USE WITH PATIENT. THIS REPORT IS 1 OF 4 FOR (B)(6):THE DEVICE THAT FAILED INSIDE THE PATIENT.

  Patient problems: Cough

  MAUDE report 14713708 ↗
• MalfunctionApr 14, 2022Failure to Fire; Failure to Fire

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING A THERAPEUTIC ESOPHAGODUODENOSCOPY WITH DILATATION AND THERAPEUTIC INJECTION (MYTOMICIN), THE DEVICE 0.1 ML OF MITOCYCIN WAS INJECTED BY PUSHING THE INJECTOR TWICE. HOWEVER, THE MEDICINE DID NOT PASS THROUGH WITH THE THIRD PUSH. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115770 ↗
• MalfunctionJan 5, 2022No Flow; No Flow

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, DURING AN UNKNOWN THERAPEUTIC PROCEDURE NO LIQUID COULD BE INJECTED FROM THE DISTAL TIP OF THE DEVICE. ANOTHER DEVICE ALSO FAILED IN THE SAME WAY AND THE PROCEDURE WAS COMPLETED WITH A THIRD SIMILAR DEVICE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171723 ↗
• MalfunctionJan 5, 2022No Flow; No Flow

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, DURING AN UNKNOWN THERAPEUTIC PROCEDURE NO LIQUID COULD BE INJECTED FROM THE DISTAL TIP OF THE DEVICE. ANOTHER DEVICE ALSO FAILED IN THE SAME WAY AND THE PROCEDURE WAS COMPLETED WITH A THIRD SIMILAR DEVICE. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171383 ↗
• MalfunctionDec 22, 2021Obstruction of Flow; Obstruction of Flow

  AN OLYMPUS REPRESENTATIVE WAS INFORMED BY THE USER FACILITY OF A REPORT THAT, UPON DEPLOYMENT OF THE OLYMPUS, MODEL NM-401L-0425 SINGLE USE INJECTOR, IT FAILED TO DISPEL FLUID; "IT GOT JAMMED." THE PROBLEM CAUSED A DELAY IN PROCEDURE OF A FEW SECONDS WHILE A NEW PACKAGE WAS OPENED; THERE WAS NO ADVERSE HEALTH EFFECT TO THE PATIENT ATTRIBUTED TO THE DELAY. THE INTENDED PROCEDURE IS UNKNOWN BUT IT WAS REPORTED THAT IT WAS LIKELY A "BOTOX" PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. THIS IS REPORT #2 OF 2 DUE TO MULTIPLE DEVICES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060811 ↗
• MalfunctionDec 22, 2021Obstruction of Flow; Obstruction of Flow

  AN OLYMPUS REPRESENTATIVE WAS INFORMED BY THE USER FACILITY OF A REPORT THAT, UPON DEPLOYMENT OF THE OLYMPUS, MODEL NM-401L-0425 SINGLE USE INJECTOR, IT FAILED TO DISPEL FLUID; "IT GOT JAMMED." THE PROBLEM CAUSED A DELAY IN PROCEDURE OF A FEW SECONDS WHILE A NEW PACKAGE WAS OPENED; THERE WAS NO ADVERSE HEALTH EFFECT TO THE PATIENT ATTRIBUTED TO THE DELAY. THE INTENDED PROCEDURE IS UNKNOWN BUT IT WAS REPORTED THAT IT WAS LIKELY A "BOTOX" PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. THIS IS REPORT #1 OF 2 DUE TO MULTIPLE DEVICES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060573 ↗
• MalfunctionApr 25, 2021Infusion or Flow Problem; Infusion or Flow Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING USING TWO DEVICES, THE FOLLOWING EVENT OCCURRED. THE DEVICES WERE CLOGGED AND THE MEDICATION COULD NOT BE INJECTED INTO THE VOCAL FOLDS. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE SECOND ONE OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722001 ↗
• MalfunctionApr 22, 2021Infusion or Flow Problem; Infusion or Flow Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING USING TWO DEVICES, THE FOLLOWING EVENT OCCURRED. THE DEVICES WERE CLOGGED AND THE MEDICATION COULD NOT BE INJECTED INTO THE VOCAL FOLDS. THERE WAS NO PATIENT INJURY REPORTED. THIS IS THE FIRST ONE OF TWO REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705148 ↗