ManoScan RFG-1286Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260167482569), received between Aug 31, 2023 and Aug 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2023Difficult to Remove; Insufficient Device Problem Information; Difficult to Remove; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK DURING EXTUBATING. THE ESOPHAGEAL CATHETER WAS STERILIZED AND CALIBRATED AS PER PROTOCOL. THE CATHETER WAS INSERTED VIA THE RIGHT NOSTRIL WITHOUT ANY RESISTANCE TO 52 CENTIMETERS. THE PROCEDURE WENT WELL WITH ROUTINE WATER SWALLOWS WITHOUT ANY COMPLICATIONS. AT THE CONCLUSION OF THE STUDY, AS THE CUSTOMER WAS PULLING THE CATHETER OUT, IT GOT STUCK AT 46 CENTIMETERS AND WOULD NOT RETRIEVE FURTHER. AT THE 46 CENTIMETER MARK, A SMALL TEAR ON THE PLASTIC SHEATH WAS VISIBLE. A DECISION WAS MADE TO INVESTIGATE FURTHER UNDER ENDOSCOPIC GUIDANCE. THE PATIENT WAS SWIFTLY MOVED TO THE ENDOSCOPY ROOM AND WAS ANESTHETIZED UNDER GENERAL ANESTHETIC WITH AN ENDOTRACHEAL TUBE INSERTED. THE ENDOSCOPE WENT INTO THE ESOPHAGUS AND THE TIP OF THE CATHETER WAS SITTING ABOVE THE CARDIO ESOPHAGEAL JUNCTION AS EXPECTED. NO MECHANICAL OBSTRUCTION WAS SEEN IN THE ENTIRE ESOPHAGUS OR IN THE OROPHARYNX. THE WHITE PART OF THE CATHETER WAS NOT VISUALIZED AND THE "OBSTRUCTION" WAS FELT TO BE IN THE NASAL PASSAGE. EYES, NOSE, AND THROAT .(ENT) SPECIALIST WAS CALLED AND THEY CAME AFTER AROUND 30 MINUTES. THEY EXAMINED THE NASAL PASSAGE USING A FLEXIBLE N ASO-ENDOSCO

  Patient problems: Airway Obstruction; Sore Throat

  MAUDE report 17663359 ↗