n.a. 10338URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551046487), received between Mar 13, 2026 and Mar 13, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMar 13, 2026Break

  THE FOLLOWING WAS REPORTED: "DURING A BRONCHOSCOPY, THE INSTRUMENTS WERE DAMAGED TRYING TO REMOVE A FOREIGN OBJECT. DUE TO THE COMPLEXITY OF THE CASE EXTRA FORCE WAS REQUIRED, WHICH IS WHY WE BELIEVE THE INSTRUMENTS WERE DAMAGED. CASE ABORTED DUE TO COMPLEXITY, NOT THE KIT. THE CASE WAS A DIFFICULT BRONCHOSCOPY WHERE THE PATIENT HAD A THUMB PIN STUCK IN THEIR AIRWAY. THE PIN WAS LODGED IN THE PATIENT AND POTENTIALLY TOO HEAVY FOR THE GRASPER, CAUSING THE GRASPER TO BREAK." CROSS REFERENCE MDR: 9610617-2026-00538.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596650 ↗
• InjuryMar 13, 2026Break

  THE FOLLOWING WAS REPORTED: "DURING A BRONCHOSCOPY, THE INSTRUMENTS WERE DAMAGED TRYING TO REMOVE A FOREIGN OBJECT. DUE TO THE COMPLEXITY OF THE CASE EXTRA FORCE WAS REQUIRED, WHICH IS WHY WE BELIEVE THE INSTRUMENTS WERE DAMAGED. CASE ABORTED DUE TO COMPLEXITY, NOT THE KIT. THE CASE WAS A DIFFICULT BRONCHOSCOPY WHERE THE PATIENT HAD A THUMB PIN STUCK IN THEIR AIRWAY. THE PIN WAS LODGED IN THE PATIENT AND POTENTIALLY TOO HEAVY FOR THE GRASPER, CAUSING THE GRASPER TO BREAK." CROSS REFERENCE MDR: 9610617-2026-00538.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596628 ↗