Gyrus ACMI BE-208Recalls & reported problems
Gyrus ACMI, LLC · Fulgurating Electrode Long Tip 2 FR (.667 mm) X 105 CM (6/PK) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925038158), received between Jun 16, 2021 and Jun 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2021Defective Device; Defective Device
A USER FACILITY REPORTED TO AN OLYMPUS SALES REPRESENTATIVE THAT THE FULGURATING ELECTRODE FRAYED TIP ON THE BLUE ISOLATING COIL OF UNDERLYING WERE INSIDE PATIENT. THERE WAS NO INFORMATION INDICATING PATIENT INJURY OR ANY ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12008830 ↗
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 WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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