M3 Gold M3-12ARecalls & reported problems
Gyrus ACMI, LLC · M3 Gold Autoclavable Operative Telescope 12, Color Coded Green · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925005662), received between Jun 29, 2021 and Aug 5, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Sharp Edges2
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Sharp Edges
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143849 ↗MalfunctionOct 21, 2024Break; Break
WHILE EVALUATING AN OLYMPUS M3-GOLD AUTOCLAVABLE TELESCOPE, IT WAS DISCOVERED THAT THE OUTER TUBE WAS DAMAGED BEYOND REPAIR AND THE IMAGE BUNDLE HAD BROKEN FIBERS PRESENT. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493429 ↗MalfunctionOct 25, 2021Break; Break
UPDATES: FURTHER COMMUNICATION WITH THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFORMATION OTHER THAN CONFIRMING THAT THERE WAS NO PATIENT INVOLVEMENT WHEN THE EVENT OCCURRED AND PROVIDED HER JOB TILE AND OCCUPATION. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12693737 ↗MalfunctionJun 29, 2021No Display/Image; Sharp Edges; No Display/Image; Sharp Edges
THE SERVICE CENTER (OCI) WAS INFORMED THAT A CUSTOMER AUTOCLAVABLE OPERATIVE 12 DEGREE TELESCOPE WAS RETURNED DUE TO A REPORT OF "SHARP EDGES AT THE TIP AND BLACK OUT LENS" THAT OCCURRED DURING REPROCESSING. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12088886 ↗
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, ClassifiedOlympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
- Z-3299-2026 · Aug 24, 2026 · Open, ClassifiedOlympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Z-2720-2026 · May 5, 2026 · Open, ClassifiedOlympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
- Z-2139-2025 · Jun 18, 2025 · Open, ClassifiedBlue 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, ClassifiedGreen 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, ClassifiedACMI 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 · TerminatedGyrus 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
Other ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL devices
- M3 Gold M3-30AGyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall11 reports
- USA Elite MLE-24-012Gyrus ACMI, LLC · ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22332DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.