Skip to content

Reusable Surgical Optical Fiber EMP-FBX272HR-CRecalls & reported problems

Quanta System SPA · Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc. · 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 08033945938536), received between Oct 13, 2022 and Oct 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K180158); 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

  • Break1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 13, 2022Break; Break

    BROKEN OPTICAL FIBER CAUSED OPERATOR'S FINGER BURN. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

    Patient problems: Burn(s)

    MAUDE report 15593628 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180158. One submission often covers many models, so check the product and lot details in each record.

  • Z-1842-2021 · Apr 27, 2021 · Terminated
    Olympus Sterile Optical Laser Fiber, single use and reusable

Other Powered Laser Surgical Instrument devices

All Powered Laser Surgical Instrument devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page