DeRoyal 81-040409Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756046008), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 injury.

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

• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO SURGERY VITALS WERE NORMAL. WHEN THE PATIENT ENTERED THE SURGICAL ROOM A DEROYAL ESOPHAGEAL STETHOSCOPE WAS PLACED FOLLOWING ANESTHESIA. SLIGHT RESISTANCE WAS OBSERVED AT THE OROPHARYNX BUT OVERALL, THE INSERTION WAS NOT VERY DIFFICULT. SURG-JELLE WAS USED AS A LUBRICANT TO EASE INSERTION. THE ESOPHAGEAL STETHOSCOPE WAS PLACED TO 30CM FROM THE UPPER LIP AND SECURED ONCE NO STRANGULATION OR BLEEDING ON THE ORAL CAVITY WAS CONFIRMED. AFTER 2HR 25 MINS OF SURGERY THE STETHOSCOPE WAS REMOVED, AND RED BLOOD WAS OBSERVED ON THE TIP OF THE STETHOSCOPE. NO BLOOD WAS FOUND DURING ENDOTRACHEAL SUCTION. A SMALL AMOUNT OF BLOOD WAS FOUND DURING INTRAORAL SUCTION. THERE WAS NO VISIBLE BLOOD ON THE TRACHEAL TUBE ONCE REMOVED. DURING POST OP THE PATIENT INTERMITTENTLY COUGHED AN INSIGNIFICANT AMOUNT OF BLOOD WHICH DECREASED OVER TIME. THE PATIENT WAS RELEASED TO THE GENERAL WARD BUT CONTINUED TO HAVE UNCLEAR COMPLAINTS THE PATIENT BEGAN COUGHING OUT BLOODY SPUTUM AND HIS BP DROPPED. $ HOURS AND 30 MINS POST OP A L TUBE WAS INSERTED, AND IRRIGATION PRESENTED BLOODY. THE LARYNGOSCOPIC EXAMINATION LED TO THE IDENTIFICATION OF A LINEAR LACERATION (1CM WIDE BY 1-2 MM DEEP). THE LACERATION WAS

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 19929635 ↗