DeRoyal 30-057Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00749756035910), received between Dec 10, 2019 and Jun 8, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Material Fragmentation

  A USER FACILITY REPORTED, "THE STRING BROKE OFF IN THE PATIENT AND HAD TO BE REMOVED BY THE SURGEON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429917 ↗
• MalfunctionMar 30, 2026Material Separation

  A USER FACILITY REPORTED, "HAD A COTTONOID THAT BASICALLY FELL APART DURING A CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729316 ↗
• MalfunctionJan 30, 2026Material Separation

  A USER FACILITY REPORTED, "PRODUCT USED IN ENDOSCOPIC SINUS SURGERY WITH EPINEPHRINE. SMALL FIBERS WERE LEFT BEHIND IN NASAL CAVITY WHEN SPONGES WERE REMOVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222137 ↗
• InjuryMay 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "FIBRE TISSUE HAD TO BE REMOVED FROM BRAIN TISSUE. LENGTH OF DELAY UNKNOWN."

  Patient problems: Insufficient Information

  MAUDE report 22055272 ↗
• InjuryMay 20, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "FIBRE TISSUE HAD TO BE REMOVED FROM BRAIN TISSUE. LENGTH OF DELAY UNKNOWN."

  Patient problems: Insufficient Information

  MAUDE report 22055260 ↗
• MalfunctionMay 12, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "THE RADIOPAQUE STRIP IS PEELING OFF THE SPONGE. MULTIPLE THIS SIZE SPONGE FROM THE SAME PACK WERE PEELING OFF. SPONGES WERE NOT SAVED AFTER THE CASE HOWEVER PICTURES WERE TAKEN AND WILL BE ATTACHED TO THIS EVENT REPORT. NOTICED ONE THAT WAS PEELING OFF DURING THE MIDDLE OF THE CASE UNDER THE MICROSCOPE. THAT ONE WAS IMMEDIATELY REMOVED. AT THE END OF THE CASE DURING THE CLOSING COUNT MORE OF THE SAME SIZE WERE PEELING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002780 ↗
• MalfunctionMay 8, 2025Extra Components; Extra Components

  A USER FACILITY REPORTED, "1/2 X 3 NEURO PATTIES COUNTED, AND THE PACK HAD 11 WHEN IT SHOULD HAVE BEEN 10."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986593 ↗
• MalfunctionMay 8, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "THE RADIOPAQUE STRIP IS PEELING OFF THE SPONGE. MULTIPLE THIS SIZE SPONGE FROM THE SAME PACK WERE PEELING OFF. SPONGES WERE NOT SAVED AFTER THE CASE HOWEVER PICTURES WERE TAKEN AND WILL BE ATTACHED TO THIS EVENT REPORT. NOTICED ONE THAT WAS PEELING OFF DURING THE MIDDLE OF THE CASE UNDER THE MICROSCOPE. THAT ONE WAS IMMEDIATELY REMOVED. AT THE END OF THE CASE DURING THE CLOSING COUNT MORE OF THE SAME SIZE WERE PEELING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986561 ↗
• MalfunctionMar 25, 2025Material Separation; Material Separation

  A USER FACILITY REPORTED, "NEURO PATTY WHERE SOME PARTS OF THE RUBBER ON TOP OF THE GAUZE ARE LOOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691585 ↗
• MalfunctionDec 10, 2019Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  THE SURGEON NOTICED THE STRING WAS NOT COMPLETELY ATTACHED TO THE SPONGE. ANOTHER PACK WAS OPENED AND THE STRING EASILY CAME OFF THE SPONGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9445832 ↗
• MalfunctionDec 10, 2019Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  THE SURGEON NOTICED THE STRING WAS NO COMPLETELY ATTACHED TO THE SPONGE. ANOTHER PACK WAS OPENED AND THE STRING EASILY CAME OFF THE SPONGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9445822 ↗