DeRoyal 81-040418Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756045988), received between Jun 28, 2018 and Aug 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Device Sensing Problem; Device Sensing Problem

  A DISTRIBUTING FACILITY REPORTED, "SENSOR MALFUNCTION. THE MACHINE COULD NOT READ THE TEMPERATURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951451 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE FIRST POSTOPERATIVE DAY IN THE WARD, SHE COMPLAINED OF MODERATE HOARSENESS. THE PHYSICIAN EXPECTED THE SYMPTOM WOULD RESOLVE SPONTANEOUSLY, BUT THE PATIENT COMPLAINED OF PERSISTENT HOARSENESS ON THE FOURTH DAY AFTER THE OPERATION. THERE WERE NO SYMPTOMS OTHER THAN HOARSENESS. ON THE SIXTH DAY AFTER THE OPERATION, FIBER-OPTIC LARYNGOSCOPY WAS PERFORMED BY THE LARYNGOLOGIST. ON LARYNGOSCOPY, THE LEFT VOCAL CORD WAS FIXED IN THE PARAMEDIAN POSITION, HOWEVER MINIMAL MOVEMENT OF ARYTENOID DURING PHONATION WAS OBSERVED. ARYTENOID DISLOCATION WAS SUSPECTED, AND SURGICAL REDUCTION UNDER GENERAL ANESTHESIA WAS PERFORMED. THE PATIENT'S VOICE WAS IMPROVED IMMEDIATELY AFTER THE SURGERY; AND A MONTH AFTER THE SURGERY, MOVEMENT OF THE VOCAL CORDS WAS COMPLETELY NORMAL

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19929636 ↗
• MalfunctionJun 28, 2018Erratic or Intermittent Display; Display or Visual Feedback Problem; Improper Device Output; Output Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem; Improper Device Output; Output Problem

  DURING PROCEDURE, THE PHYSICIAN REQUESTED READING OF TEMPERATURE PROBE. A NURSE STATED THAT NUMBERS WERE FLUCTUATING AND NOT DEPENDABLE. PROBE WAS WITHDRAWN AND NEW PROBE INSERTED WITH NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645110 ↗