aScope™ 5 Broncho HD 5.0/2.2 Sampler Set 621002000USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480156511), received between Oct 28, 2025 and Oct 28, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 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.

• InjuryOct 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PATIENT IN FOR AN OUTPATIENT BRONCHOSCOPY WITH WASHINGS, BRUSHINGS, AND POSSIBLE BIOPSY UNDER GENERAL ANESTHESIA (WITH A LMA [LARYNGEAL MASK AIRWAY]) DUE TO LEFT LOWER LOBE INFILTRATES, CONSOLIDATION, AND MASS. PROCEDURE PERFORMED BY DR. PT WAS IN THE ROOM BY 0745, PROCEDURE STARTED AT 0757 AFTER A PAUSE AT 0756. PROCEDURE WAS GOING AS PLANNED, AFTER TWO LAVAGES AND MULTIPLE WASHINGS DUE TO MUCOUS PLUGGING, MD STATED HE WOULD LIKE TO GET A BRUSHING OF LEFT LOWER LOBE. WRITER OPENED BRUSHING PACKAGE, VISUAL INSPECTION OF BRUSH WAS COMPLETED, AND BRUSH WAS HANDED TO DR. MD INSERTED BRUSH INTO BIOPSY CHANNEL AS USUAL, BRUSH WAS OBSERVED COMING OUT OF BIOPSY CHANNEL AT END OF SCOPE INSIDE THE BRONCHIAL, AFTER MD INSTRUCTED WRITER TO DEPLOY BRUSH OUT, BRUSH WAS DEPLOYED, AND UPON BRUSHING COMING OUT OF SHEATH COVER, WRITER, DR, DR. NOTICED SOMETHING WHITE TO THE LEFT SIDE OF SCREEN, NEXT TO BRUSH. ONCE BRUSH WAS RETRACTED, AND REMOVED FROM BIOPSY CHANNEL, AN OBVIOUS WHITE PIECE OF FOREIGN BODY WAS NOTED INSIDE THE BRONCHUS. MD ATTEMPTED RETRIEVAL WITH A BIOPSY FORCEP, WHICH FAILED, MD NOTED THAT FORCEP WAS DIFFICULT TO ADVANCE INTO BIOPSY CHANNEL, MD DID A VISUAL INSPECTION OF THE BRONC

  Patient problems: Foreign Body In Patient

  MAUDE report 23405766 ↗
• InjuryOct 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PATIENT IN FOR AN OUTPATIENT BRONCHOSCOPY WITH WASHINGS, BRUSHINGS, AND POSSIBLE BIOPSY UNDER GENERAL ANESTHESIA (WITH A LMA [LARYNGEAL MASK AIRWAY]) DUE TO LEFT LOWER LOBE INFILTRATES, CONSOLIDATION, AND MASS. PROCEDURE PERFORMED BY DR. PT WAS IN THE ROOM BY 0745, PROCEDURE STARTED AT 0757 AFTER A PAUSE AT 0756. PROCEDURE WAS GOING AS PLANNED, AFTER TWO LAVAGES AND MULTIPLE WASHINGS DUE TO MUCOUS PLUGGING, MD STATED HE WOULD LIKE TO GET A BRUSHING OF LEFT LOWER LOBE. WRITER OPENED BRUSHING PACKAGE, VISUAL INSPECTION OF BRUSH WAS COMPLETED, AND BRUSH WAS HANDED TO DR. MD INSERTED BRUSH INTO BIOPSY CHANNEL AS USUAL, BRUSH WAS OBSERVED COMING OUT OF BIOPSY CHANNEL AT END OF SCOPE INSIDE THE BRONCHIAL, AFTER MD INSTRUCTED WRITER TO DEPLOY BRUSH OUT, BRUSH WAS DEPLOYED, AND UPON BRUSHING COMING OUT OF SHEATH COVER, WRITER, DR, DR. NOTICED SOMETHING WHITE TO THE LEFT SIDE OF SCREEN, NEXT TO BRUSH. ONCE BRUSH WAS RETRACTED, AND REMOVED FROM BIOPSY CHANNEL, AN OBVIOUS WHITE PIECE OF FOREIGN BODY WAS NOTED INSIDE THE BRONCHUS. MD ATTEMPTED RETRIEVAL WITH A BIOPSY FORCEP, WHICH FAILED, MD NOTED THAT FORCEP WAS DIFFICULT TO ADVANCE INTO BIOPSY CHANNEL, MD DID A VISUAL INSPECTION OF THE BRONC

  Patient problems: Foreign Body In Patient

  MAUDE report 23400282 ↗