ManoScan RFG-3890Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04260167482507), received between Nov 26, 2018 and Aug 23, 2023 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 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 17603719 ↗
• MalfunctionAug 23, 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 17603624 ↗
• MalfunctionAug 23, 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 17603613 ↗
• MalfunctionAug 23, 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 17603554 ↗
• MalfunctionJun 21, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK IN THE PATIENT¿S NASAL PASSAGE UPON INTUBATION. CUSTOMER WAS ASKING FOR GUIDANCE ON HOW TO REMOVE THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8725085 ↗
• MalfunctionApr 10, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT CAME IN FOR AN ESOPHAGEAL MOTILITY TEST. THE PROBE WAS INSERTED AND TOLERATED WITHOUT DIFFICULTY AND THE PROCEDURE WAS DONE. WHEN THE NURSE ATTEMPTED TO REMOVE THE PROBE FROM THE PATIENT¿S NOSE, IT CAME OUT EASILY UNTIL 44 ¿ 45 CENTIMETERS AND THEN IT COULD NOT BE PULLED OUT ANY FURTHER. DIFFERENT ANGLES WERE TRIED, AND MORE LUBE WAS APPLIED, BUT THE PROBE WOULD NOT COME OUT ANY FURTHER THAN 45 CENTIMETERS. THE PATIENT¿S FAMILY WAS BROUGHT IN TO SIT WITH THEM AND THE NURSE WENT TO SEE IF ANYONE COULD SUGGEST A POSSIBLE SOLUTION. THE PHYSICIAN WAS IN ANOTHER PROCEDURE AND SUGGESTED MORE LUBE AND REINSERTING THE PROBE INTO THE STOMACH AND PULLING OUT, BUT THIS DID NOT WORK. WHEN THE PHYSICIAN WAS DONE WITH HIS OTHER PROCEDURE, SEVERAL ATTEMPTS OF REMOVING THE PROBE FROM THE PATIENT¿S NOSE WAS MADE BUT WAS ALSO UNSUCCESSFUL. EVENTUALLY, THEY WERE ABLE TO PULL THE END OF THE PROBE OUT OF THE PATIENT¿S MOUTH. THE CATHETER POSITIONED THEN WAS CUT SO IT COULD BE REMOVED. THE CATHETER HAD BEEN SUCCESSFULLY REMOVED FROM AT LEAST 50 OTHER NARES WITHOUT INCIDENT. AFTER THE PROBE WAS REMOVED, THE PATIENT WALKED OUT OF THE HOSPITAL WITH NO COMPLAINTS OF PA

  Patient problems: No Code Available

  MAUDE report 8501139 ↗
• InjuryJan 24, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT PROCESS, THE CATHETER GOT STUCK ON A BONE AND WAS UNABLE TO BE REMOVED. THE PHYSICIAN HAD TO USE A SCOPE TO LOCATE AND REMOVE IT. THE PATIENT DID NOT BLEED AND WAS STABLE, AND THE STUDY WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8276676 ↗
• InjuryNov 26, 2018Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, WHEN THEY ATTEMPTED TO EXTUBATE THE PATIENT, BUT THE PROBE WAS STUCK, AND THEY HAD A DIFFICULTY REMOVING IT. THEY HAD TO CONTACT THE EARS, NOSE, THROAT (ENT) DEPARTMENT WHICH TOOK 2 HOURS. THE CATHETER WAS IN THE PATIENT'S CRICOTHYROID AND THEY HAD TO USE A SCOPE TO CHECK THE LOCATION AND REMOVE IT. THE PATIENT EXPERIENCE BLEEDING IN THE NASAL CAVITY, BUT THEY WERE ABLE TO STOP THE BLEEDING AND THE PATIENT WAS STABLE. THEY WILL NOT REPEAT THE STUDY. TECHNICAL SUPPORT CONNECTED TO THE SYSTEM AND COMPLETED A SEARCH FOR THE FILE BUT WAS STILL UNABLE TO FIND THE STUDY.

  Patient problems: Blood Loss

  MAUDE report 8100693 ↗