Biopsy Forceps - Smooth Cup MBR-000014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B634MBR0000140), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K173760); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY A PATIENT WAS BLEEDING IN THE RIGHT MIDDLE LOBE FOLLOWING THE USE OF A MEDTRONIC ARCPOINT NEEDLE AND THE MONARCH FORCEPS. THE BLEEDING OBSTRUCTED THE PHYSICIAN¿S VIEW AND WAS NOTED IN THE ENDOTRACHEAL TUBE. THE MONARCH PORTION OF THE CASE WAS ABORTED, AND THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION TO REMOVE THE ROBOT AND ATTEMPTED TO CONTROL THE BLEEDING. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND TRANSPORTED TO THE OPERATING ROOM (OR). WHEN IN THE OR, THE PHYSICIAN, WHILE UNDER BRONCHOSCOPIC GUIDANCE, WAS ABLE TO CONTROL THE BLEEDING VIA BRONCHOSCOPE VISUALIZATION AND EPINEPHRINE. PATIENT WAS DISCHARGED TWO DAYS LATER AND IS DOING WELL. NO FAULTS OR MALFUNCTIONS WERE REPORTED FROM SYSTEM. THE MONARCH FORCEPS WERE DISCARDED DURING THE EVENT AND WILL NOT BE RETURNED FOR FAILURE ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15336094 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173760. One submission often covers many models, so check the product and lot details in each record.

• Z-0025-2020 · Apr 19, 2019 · Terminated
  Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120