ManoScan 3890Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 04260167482446), received between Jun 11, 2018 and Sep 18, 2026 — classified as 31 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (78 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Insert; Difficult to Remove; Loss of Data

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829201 ↗
• InjuryJun 20, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE IMPEDANCE CATHETER GOT STUCK IN A PATIENT¿S NARES. IT WAS INSERTED EASILY AND THE TEST COMPLETED, BUT UPON REMOVAL IT ONLY CAME OUT TO THE 41CM MARK (ABOUT 10 CM). IT COULD NOT BE REMOVED BY EITHER THE NURSES OR DOCTOR WITH THE PATIENT AWAKE AS SIGNIFICANT NASAL PAIN AND EMOTIONAL DISTRESS EXPERIENCED. PATIENT WAS THUS SEDATED IN THE ENDOSCOPY SUITE AND A GASTROSCOPY WAS DONE TO ENSURE THE CATHETER WAS NOT ¿STUCK¿ IN THE ESOPHAGUS OR STOMACH. EVERYTHING LOOKED NORMAL BELOW THE UPPER ESOPHAGEAL SPHINCTER, SO THE ISSUE OF RESISTANCE WAS IN THE PATIENT'S NASAL CAVITY. AFTER SEVERAL ATTEMPTS THE PHYSICIAN WAS ABLE TO REMOVE IT AND THE PATIENT WAS RECOVERED FROM SEDATION.

  Patient problems: Distress; Pain

  MAUDE report 22297286 ↗
• MalfunctionJun 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROBE BECAME STUCK IN THE PATIENT'S NASAL PASSAGE UPON REMOVAL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283316 ↗
• MalfunctionMar 4, 2025Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CATHETER WHITE PLASTIC HAS DISLODGED AND, ALTHOUGH IT CALIBRATES AND WORKS CORRECTLY, WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S NOSE, IT BECOMES STUCK. THE CATHETER WAS REMOVED CAREFULLY. THERE WAS NO ANY ADDITIONAL DEVICE NEEDED TO REMOVE THE CATHETER FROM THE PATIENT. THERE WAS NO PATIENT OR USER HARM. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516318 ↗
• MalfunctionJan 24, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A CATHETER BECAME STUCK IN THE PATIENT'S NARES DURING ITS REMOVAL. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228819 ↗
• InjuryOct 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ESOPHAGOGASTRODUODENOSCOPY ASSIST. IT WAS CONFIRMED TO BE IN THE STOMACH. WHILE THE PATIENT WAS IN THE RECOVERY WAITING ROOM, THE "VOMITING" STARTED. IT WAS OBSERVED THAT THE CATHETER COILED UP IN THE BACK OF THE PATIENT¿S THROAT, FURTHER STIMULATING THE GAG REFLEX. THERE WAS NO DIFFICULTY PULLING THE CATHETER FROM THE PATIENT. NO RESISTANCE FELT. THE PATIENT WAS FINE, AND THE VOMITING STOPPED AFTER THE CATHETER WAS REMOVED. NO OTHER DEVICES WERE USED TO REMOVE THE CATHETER. IT WAS PULLED OUT IN THE MANNER OF REMOVING AN NG TUBE. AN X-RAY WAS ORDERED TO CONFIRM THAT THERE WAS NO INJURY.

  Patient problems: Vomiting

  MAUDE report 20510247 ↗
• InjurySep 25, 2024Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN PATIENT'S NOSE. ENT (EAR, NOSE, THROAT) TEAM TOOK ONE OF ENT (EAR, NOSE, THROAT) SCOPES AND CUT THE DEVICE TO GET IT OUT OF PATIENT'S NOSE. FORCEPS WAS ALSO USED TO REMOVE THE CATHETER FROM THE PATIENT. THE CATHETER WAS DAMAGED.

  Patient problems: Airway Obstruction

  MAUDE report 20305248 ↗
• InjurySep 24, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN A PATIENT'S NOSE AND HAD TO BE REMOVED. THE CATHETER WAS CUT, PUSHED THROUGH THE PATIENT'S NOSE AND PULLED OUT OF MOUTH WITH FORCEPS. THE EAR, NOSE AND THROAT SPECIALIST TOOK A SCOPE TO LOOK IN PATIENT'S NOSE PRIOR TO PULLING DEVICE OUT AND AFTER REMOVAL. THE CATHETER WAS DAMAGED.

  Patient problems: Airway Obstruction

  MAUDE report 20294610 ↗
• MalfunctionJul 22, 2024Poor Quality Image; Difficult to Remove; Poor Quality Image; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER HAD GREY LINES ON STUDY. IT WAS STUCK ON PATIENT WHEN BEING REMOVED. PATIENT TURNED PROBE AND IT CAME OUT. PATIENT HAD A BLOODY NOSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792778 ↗
• MalfunctionMay 15, 2024Poor Quality Image; Difficult to Remove; Material Deformation; Poor Quality Image; Difficult to Remove; Material Deformation

  ACCORDING TO THE REPORTER, THE CATHETER WAS DAMAGED DURING A DIFFICULT EXTUBATION. WHEN CALIBRATION WAS ATTEMPTED, IT SHOWED MULTIPLE PRESSURE BANDS. THE TPE SENSORS ALSO FELT TO BE STICKING OUT FURTHER THAN THE OTHER CATHETER. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325619 ↗
• MalfunctionApr 16, 2024Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER WAS DAMAGED. THE INNER WHITE LINING IS DEGRADED <(>&<)> STRUCTURE IS COMPROMISED. A PROBLEM WAS ENCOUNTERED AT THE END OF THE STUDY AT NASAL CANAL, THE CATHETER WAS DIFFICULT TO EXTUBATE, IT WAS STUCK. THERE WAS NO MEDICAL INTERVENTION PERFORMED TO REMOVE THE CATHETER. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116484 ↗
• MalfunctionMar 29, 2024Difficult to Remove; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information; Difficult to Remove; Manufacturing, Packaging or Shipping Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER WAS DIFFICULT TO INTUBATE AND EXTUBATE AS THE SENSORS APPEARED TO BE MISALIGNED, THIS WAS THE FIRST USE OF THE CATHETER. THERE WAS NO PATIENT AND USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19003750 ↗
• InjuryJan 31, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS UNABLE TO BE REMOVED FROM PATIENT'S NARE. IT WENT IN WITHOUT RESISTANCE. THEY ATTEMPTED MULTIPLE TIMES TO REMOVE IT WITH THE POOR PATIENT WRITHING IN PAIN. THE PHYSICIAN CAME TO ASSIST AND COULD NOT GET IT EITHER. THEY ENDED UP HAVING TO CUT THE CATHETER AND RETRIEVED IT ORALLY. PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 18616019 ↗
• InjuryJan 22, 2024Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK IN PATIENT'S NOSTRIL. RESISTANCE WAS FELT UPON REMOVAL OF PROBE. PATIENT COMPLAINED OF PAIN. PATIENT'S ENT PHYSICIAN WAS CONTACTED AND PATIENT WAS BROUGHT IMMEDIATELY TO ENT'S OFFICE. THE PROBE WAS REMOVED UNDER DIRECT VISUALIZATION OF NASAL SCOPE. CUSTOMER ADVISED THAT THERE WAS A BLOOD STAIN INSIDE THE CATHETER. IT WAS CAUSED BY A TEAR OF A VERY SMALL PIECE OF TISSUE THAT CAME OUT FROM PATIENT'S NOSTRIL UPON REMOVAL OF THE PROBE. NO BLEEDING WAS NOTED. PATIENT WAS STABLE.

  Patient problems: Pain

  MAUDE report 18552764 ↗
• MalfunctionDec 13, 2023Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER HAD A ROUGH SPOT ON THE CATHETER ABOVE THE METAL RING. THE CUSTOMER WAS AFRAID IT WILL INJURE A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317528 ↗
• MalfunctionNov 6, 2023Difficult to Remove; Failure to Calibrate; Difficult to Remove; Failure to Calibrate

  ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN THE PATIENT BUT WAS ABLE TO GET IT OUT. THE CUSTOMER WANTED TO CHECK THE CATHETER BECAUSE IT FAILED TO CALIBRATE. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079075 ↗
• MalfunctionOct 3, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN A PATIENT. ABOUT 1 INCH FROM END FELT LIKE THERE WAS A ROUGH SPOT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17866032 ↗
• InjuryOct 3, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN A PATIENT. ABOUT 1 INCH FROM END FELT LIKE THERE WAS A ROUGH SPOT. SURGERY WAS DONE TO HAVE THE CATHETER REMOVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17863051 ↗
• MalfunctionSep 14, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER STUCK IN A PATIENT THAT HAD TO BE REMOVED BY THE EAR, NOSE AND THROAT CONSULTANT. THE PATIENT HAS A SMALL NASAL SEPTUM THE CATHETER WENT DOWN WITH NO PROBLEMS HOWEVER UPON REMOVAL THE CATHETER BECOME STRUCK IN THE TURBINATE¿S. THE PATIENT DID NOT SUFFER ANY OBSTRUCTIONS IN THE NOSE AND DID NOT SUFFER ANY BLEEDING DURING THE REMOVAL OF THE CATHETER. THE PATIENT RETURNED AND HAD A REPEAT PROCEDURE WITH NO PROBLEMS WENT DOWN THE OTHER NASAL PASSAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745487 ↗
• MalfunctionAug 16, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE TPE OF THE CATHETER FELT ROUGH ON CERTAIN SPOTS. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560057 ↗
• MalfunctionAug 3, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE CATHETER HAD A ROUGH SPOT ON THE SENSOR PORTION AND IT WAS DIFFICULT TO INSERT AND REMOVE FROM THE PATIENT. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453672 ↗
• MalfunctionJul 3, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER GOT STUCK IN THE PATIENT'S NOSE AND HAD TO BE REMOVED. IT WAS SHOWING A BAD SENSOR 8. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: Airway Obstruction; Nasal Obstruction

  MAUDE report 17246846 ↗
• MalfunctionJun 21, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT HAD A CATHETER STUCK IN NOSE. AFTER COMPLETION OF THE STUDY, THEY WERE TRYING TO REMOVE THE PROBE AND COULD NOT REMOVED AT FIRST. THE NURSE HELPED THE PATIENT RELAX IN ORDER FOR THE PROBE TO BE PROPERLY REMOVED AND CAUSED NOSEBLEED. IT DID NOT CAUSE TRAUMA ON BOTH PATIENT AND THE PROBE. THE PATIENT WAS STABLE AND DID NOT REQUIRE EXTRA MED INTERVENTION.

  Patient problems: Airway Obstruction; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17176201 ↗
• MalfunctionJun 12, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK IN THE PATIENT NOSE. LUBRICANT WAS USED AND HAD TO TWIST THE PROBE AND CONTINUOUSLY LUBRICATE. CUSTOMER STATED IT WAS NOTICED THAT TPE WAS DAMAGED ONCE THE CATHETER WAS REMOVED FROM THE PATIENT NOSE. THERE WAS NO BLEEDING AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113515 ↗
• MalfunctionJun 12, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS VERY CHALLENGING TO REMOVE. IT HAD TO BE FORCEFULLY REMOVED AND EACH RIDGE WAS HEARD COMING OUT OF THE PATIENT'S NOSE. THE PATIENT HAD DISCOMFORT WHEN THE CATHETER WAS REMOVED AND MINIMAL AMOUNT OF BLOOD WAS NOTED. THE PATIENT WAS DOING FINE AT DISCHARGE.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17112044 ↗