USA Elite RBRecalls & reported problems
Gyrus ACMI, LLC · ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm) (6/PK) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925036444), received between Nov 17, 2023 and Nov 17, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (1 report).
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.
Reports received per month
Recalls naming this device
- Oct 2, 2023Open, Classified
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Z-0568-2024 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Sparking1
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.
MalfunctionNov 17, 2023Sparking; Sparking
THE CUSTOMER REPORTED TO OLYMPUS THAT THE ROLLER BAR (6/PK) HAD A SPARK/LIGHT AND THEN SMELLED DIFFERENT. THE EVENT OCCURRED DURING A PROCEDURE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18161150 ↗
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, ClassifiedOlympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Z-3300-2026 · Aug 24, 2026 · Open, ClassifiedOlympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
- 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-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
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- 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.