NA 0233050090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327051636), received between Aug 6, 2018 and Oct 12, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flare or Flash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K082813); 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2021No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT/IMAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615672 ↗
• MalfunctionAug 6, 2018Overheating of Device; Flare or Flash

  IT WAS REPORTED THAT THE LIGHT LEAD WAS USED DURING A CASE AND FLICKERED DURING THE PROCEDURE. THE CUSTOMER FURTHER REPORTED THAT THE LEAD APPEARED TO GET HOT WITH STAFF REPORTED THAT THEY COULD SMELL BURNING. PLEASE NOTE NO BURN WAS REPORTED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7754653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082813. One submission often covers many models, so check the product and lot details in each record.

• Z-1474-2023 · Mar 2, 2023 · Open, Classified
  SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200