Skip to content

Single use Surgical Optical Fiber OAF002701Recalls & reported problems

Quanta System SPA · Single use Surgical Optical Fiber ø 272µm · Class 2

All models of Single use Surgical Optical Fiber (18)

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 08033945933609), received between Jan 30, 2020 and Jan 30, 2020 — classified as 1 malfunction.

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

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
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 30, 2020Defective Device; Material Integrity Problem; Material Integrity Problem

    THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9647517 ↗

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