NA 03.605.000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034712321), received between Jul 18, 2024 and Jul 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

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.

• MalfunctionJul 26, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAFF HAD A 3MM RONGEUR RETURNING FROM THE FIELD WITH A BROKEN JAW. THIS WAS NOTED DURING INCOMING INSPECTION FROM THE FIELD IN THE WAREHOUSE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR CONSEQUENCE. THIS REPORT INVOLVES ONE DISC RONGEUR UP-BITING 3MM WIDTH 330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19837879 ↗
• MalfunctionJul 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING ON (B)(6) 2024, THE STAFF NOTICED THAT THE UPPER METAL JAW OF THE GRASPING ASPECT OF THE INSTRUMENT HAD BROKEN OFF. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE DISC RONGEUR UP-BITING 3MM WIDTH 330MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19770530 ↗