DB-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816469020004), received between Oct 25, 2019 and Oct 25, 2019 — 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 (K030959); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 25, 2019Break

  THE PT WAS HAVING A SURGICAL PROCEDURE DONE WHEN PART OF THE LASER FIBER BROKE OFF OF THE INSTRUMENT. THE SURGEON WAS ABLE TO RETRIEVE ALL PARTS AND NO HARM WAS NOTED TO THE PT. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244812 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030959. One submission often covers many models, so check the product and lot details in each record.

• Z-2073-2014 · Jun 20, 2014 · Terminated
  LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology