NA 0400800100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540502650), received between Oct 2, 2018 and Apr 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 24, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD MATERIAL THAT WAS SPLIT, CUT, OR TORN DUE TO EXTERNAL OR INTERNAL FORCES. 2 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9997092 ↗
• MalfunctionOct 2, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, A WHITE FOREIGN MATERIAL DROPPED OFF THE HOOD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925637 ↗