M3 Gold REXM3-30ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00821925007802), received between Apr 12, 2021 and Oct 21, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (6 reports).

7 other recalls cover devices cleared under the same FDA submission (K890328); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2024Thermal Decomposition of Device; Peeled/Delaminated; Thermal Decomposition of Device; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE DISTAL TIP OF THE REPAIR SCOPE WAS BURNED AND HAD A PEELING METAL PIECE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20493280 ↗
• MalfunctionSep 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE REPAIR SCOPE AUTOCLAVABLE EXHIBITED A BURNT TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160549 ↗
• MalfunctionSep 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RIGID ENDOSCOPE TELESCOPE'S DISTAL TIP WAS BURNT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157096 ↗
• MalfunctionJul 26, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THE TELESCOPE HAD A BURNT TIP, CAUSING A SHARP EDGE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT NOR PROCEDURAL INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844605 ↗
• MalfunctionJun 11, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE DISTAL END OF THE RIGID SCOPE HAD BURN DAMAGE AND WAS SHARP. THIS ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVED AND THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509716 ↗
• MalfunctionMay 30, 2024Thermal Decomposition of Device; Peeled/Delaminated; Sharp Edges; Thermal Decomposition of Device; Peeled/Delaminated; Sharp Edges

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FOROBLIQUE TELESCOPE EXHIBITED A BURNT/SHARP TIP, AS A PIECE OF METAL WAS PEELING FROM THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19428108 ↗
• MalfunctionFeb 21, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED, THE AUTOCLAVABLE FOROBLIQUE TELESCOPE HAD BURNING ON THE TIP, LEAVING A SHARP AREA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754252 ↗
• MalfunctionJan 17, 2024Sharp Edges; Sharp Edges

  THE CUSTOMER REPORTED TO OLYMPUS THE M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG, DISTAL END BURNING CAUSING SHARP EDGES. THE ISSUE OCCURRED DURING THE REPROCESSING. THE PROCEDURE WAS DIAGNOSTIC. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THERE IS A RELATED RECORD UNDER: (B)(6); MD 01/17/2024 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528157 ↗
• MalfunctionJan 17, 2024Sharp Edges; Sharp Edges

  THE CUSTOMER REPORTED TO OLYMPUS THE M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG, DISTAL END BURNING CAUSING SHARP EDGES. THE ISSUE OCCURRED DURING THE REPROCESSING. THE PROCEDURE WAS DIAGNOSTIC. THERE ARE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526937 ↗
• MalfunctionSep 18, 2023Break; Break

  THE CUSTOMER REPORTED THAT WHILE REPROCESSING HIS OLYMPUS M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE THE LENS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764357 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT A DOCTOR COMPLAINED IF THERE WERE "ISSUES WITH SCOPE". A PATIENT REPORTEDLY SUSTAINED AN UNSPECIFIED INJURY AND HAD TO GO TO THE HOSPITAL. THE DEVICE IN QUESTION WAS AN M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17715536 ↗
• MalfunctionOct 31, 2022Thermal Decomposition of Device; Mechanical Problem; Thermal Decomposition of Device; Mechanical Problem

  IT WAS REPORTED " TIP BURNT AT THE END OF SCOPE". THE ISSUE FOUND AT REPROCESSING. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705303 ↗
• MalfunctionNov 30, 2021Break; Poor Quality Image; Break; Poor Quality Image

  AS REPORTED, THE SCOPE IS BLURRY AND SHARP ON END NEAR THE LENS WERE OBSERVED. THE ISSUE FOUND DURING REPROCESSING. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889117 ↗
• MalfunctionApr 12, 2021Break; Break

  UPDATES ON THE EVENT REPORTED: THE PATIENT WAS UNDERGOING A LITHOTRIPSY AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11652720 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K890328. One submission often covers many models, so check the product and lot details in each record.

• Z-3299-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
• Z-3300-2026 · Aug 24, 2026 · Open, Classified
  Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
• Z-2720-2026 · May 5, 2026 · Open, Classified
  Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
• Z-2139-2025 · Jun 18, 2025 · Open, Classified
  Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some
• Z-2140-2025 · Jun 18, 2025 · Open, Classified
  Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the work
• Z-0568-2024 · Oct 2, 2023 · Open, Classified
  ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF M
• Z-1952-2018 · Apr 17, 2018 · Terminated
  Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs t