n.a. 226820Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551079959), received between Jan 27, 2020 and Jan 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2020Material Separation; Material Separation

  PER A VIGILANCE REPORT RECEIVED FROM THE FACTORY IN (B)(4), ALLEGEDLY, THERE WAS AN EVENT THAT OCCURRED AT A HEALTHCARE FACILITY IN (B)(6). THE DISTAL END OF THE INSTRUMENT, A ROUND KNIFE, BROKE DURING THE PROCEDURE AND THE PROCEDURE WAS ABORTED. CUSTOMER CONFIRMED THAT THE BROKEN FRAGMENT DID NOT REMAIN IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9634510 ↗