M3 Gold M3-30ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00821925005679), received between Nov 11, 2020 and Aug 26, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

1. Aug 24, 2026Open, Classified

   There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

   Z-3299-2026 · Root cause: Process control · FDA record ↗

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.

• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456819 ↗
• MalfunctionAug 18, 2026Sharp Edges

  The customer reported sharp edge on the lens part during an inspection for use involving an Olympus Hysteroscope (And Accessories). There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50301613 ↗
• MalfunctionApr 6, 2026Crack

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FOROBLIQUE TELESCOPE HAD CRACKED OBJECTIVE COVER GLASS AND BROKEN COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792894 ↗
• MalfunctionMar 31, 2026Break; Environmental Particulates

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE HYSTEROSCOPE AND ACCESSORIES EXHIBIT CHIPPED OBJECTIVE LENS AND BROKEN COVER GLASS ALSO DUST PARTICLES WERE FOUND UNDER THE EYEPIECE WINDOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747503 ↗
• MalfunctionMar 6, 2026Sharp Edges

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE (AND ACCESSORIES) EXHIBITED DISTAL END DENTS, SHARP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533481 ↗
• MalfunctionFeb 10, 2026Degraded

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306495 ↗
• MalfunctionJan 28, 2026Failure to Clean Adequately

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202230 ↗
• MalfunctionNov 19, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE DISTAL TIP OF THE RIGID SCOPE WAS SHARP. THE ISSUE WAS FOUND DURING RECEIPT OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596119 ↗
• MalfunctionJul 26, 2024Material Separation; Sharp Edges; Material Separation; Sharp Edges

  IT WAS REPORTED THE HYSTEROSCOPE HAD BURNT TIP AND SHARP EDGE CAUSING SEPARATION ON THE LENS. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19838120 ↗
• MalfunctionJun 11, 2024Material Integrity Problem; Sharp Edges; Material Integrity Problem; Sharp Edges

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE HYSTEROSCOPE DISTAL TIP WAS FOUND TO BE BURNT AND SHARP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509881 ↗
• MalfunctionNov 11, 2020Material Twisted/Bent; Material Twisted/Bent

  OLYMPUS WAS INFORMED THAT DURING PREPARATION FOR USE, THE AUTOCLAVABLE FOROBLIQUE 30 DEGREE TELESCOPE'S OUTER TUBE WAS FOUND BENT. THERE WAS NO PATIENT INVOLVEMENT, AND NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10825715 ↗

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-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-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-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-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