aScope™ 4 Broncho Regular 5.0/2.2 477001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05707480135509), received between Feb 4, 2022 and Mar 19, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING MINIMAL INVASIVE IVOR LEWIS PROCEDURE, AFTER PERFORMING MULTIPLE BRONCHOSCOPIES INTRAOPERATIVELY, THE END OF THE SINGLE-USE FIBER OPTIC SUDDENLY GOT STUCK IN THE DOUBLE LUMEN TUBE. AS PER THE CUSTOMER, THIS WAS BECAUSE THE TUBE SIMPLY FELL APART. NO APPLICATION OF FORCE. THE TIP SIMPLY FELL OFF AND BLOCKED THE TUBE, MAKING VENTILATION IMPOSSIBLE. THE PATIENT THEN HAD TO BE INTUBATED. THE PATIENT HAS NOT SUFFERED ANY DAMAGE AS A RESULT OF THIS INCIDENT.

  Patient problems: Airway Obstruction

  MAUDE report 21645188 ↗
• InjuryMar 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING MINIMAL INVASIVE IVOR LEWIS PROCEDURE, AFTER PERFORMING MULTIPLE BRONCHOSCOPIES INTRAOPERATIVELY, THE END OF THE SINGLE-USE FIBER OPTIC SUDDENLY GOT STUCK IN THE DOUBLE LUMEN TUBE. AS PER THE CUSTOMER, THIS WAS BECAUSE THE TUBE SIMPLY FELL APART. NO APPLICATION OF FORCE. THE TIP SIMPLY FELL OFF AND BLOCKED THE TUBE, MAKING VENTILATION IMPOSSIBLE. THE PATIENT THEN HAD TO BE INTUBATED. THE PATIENT HAS NOT SUFFERED ANY DAMAGE AS A RESULT OF THIS INCIDENT.

  Patient problems: Airway Obstruction

  MAUDE report 21643683 ↗
• MalfunctionFeb 17, 2023Mechanical Problem; Mechanical Problem

  DISTAL TIP DETACHED FROM THE BRONCHOSCOPE DURING PROCEDURE. THE SCOPE WAS REMOVED FROM THE PATIENT IMMEDIATELY. PATIENT OUTCOME NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399376 ↗
• MalfunctionFeb 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DISTAL TIP DETACHED FROM THE BRONCHOSCOPE DURING PROCEDURE. THE SCOPE WAS REMOVED FROM THE PATIENT IMMEDIATELY. PATIENT OUTCOME NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16395800 ↗
• MalfunctionJul 12, 2022Tear, Rip or Hole in Device Packaging

  AN ASCOPE 4 BRONCHO REGULAR BRONCHOSCOPE WAS USED INSTEAD OF THE SLIM. DURING USE, THE TIP OF THE BRONCHOSCOPE WAS TEARED INSIDE THE PATIENT'S TUBUS. THE CUSTOMER NOTED THAT THIS HAPPENED DUE TO IMPROPER USE (NOT ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS). PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14985797 ↗
• MalfunctionJul 8, 2022Use of Device Problem; Use of Device Problem

  AN ASCOPE 4 BRONCHO REGULAR BRONCHOSCOPE WAS USED INSTEAD OF THE SLIM. DURING USE, THE TIP OF THE BRONCHOSCOPE WAS TEARED INSIDE THE PATIENT'S TUBUS. THE CUSTOMER NOTED THAT THIS HAPPENED DUE TO IMPROPER USE (NOT ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS). PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14952832 ↗
• InjuryMay 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  THE TIP OF AN AMBU ASCOPE 4 BRONCHO REGULAR BROKE OFF INSIDE THE ENDOTRACHEAL AIRWAY TUBE OF A PATIENT. THE PHYSICIAN USED ANOTHER SCOPE TO CONFIRM THAT NOTHING WAS LODGED IN THE PATIENT. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14347583 ↗
• InjuryMay 10, 2022Break

  THE TIP OF AN AMBU ASCOPE 4 BRONCHO REGULAR BROKE OFF INSIDE THE ENDOTRACHEAL AIRWAY TUBE OF A PATIENT. THE PHYSICIAN USED ANOTHER SCOPE TO CONFIRM THAT NOTHING WAS LODGED IN THE PATIENT. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347576 ↗
• MalfunctionFeb 7, 2022Break; Physical Resistance/Sticking

  DURING A SUBACUTE BRONCHOSCOPY THE BRONCHOSCOPE GOT STUCK IN THE TUBE AND THE DISTAL PART OF THE SCOPE BROKE OFF AND ENDED IN THE MAIN BRONCHI AND HAD TO BE RETRIEVED. THE SCOPE WAS USED WITH ET TUBE 8.00 MM AND WAS UNABLE TO MOVE UP AND DOWN. THE TUBE WAS UNAFFECTED AND HAD NO TRACES OF DAMAGE OR DEFORMITY. THE PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13471947 ↗
• MalfunctionFeb 4, 2022Material Fragmentation; Material Fragmentation

  DURING A SUBACUTE BRONCHOSCOPY THE BRONCHOSCOPE GOT STUCK IN THE TUBE AND THE DISTAL PART OF THE SCOPE BROKE OFF AND ENDED IN THE MAIN BRONCHI AND HAD TO BE RETRIEVED. THE SCOPE WAS USED WITH ET TUBE 8.00 MM AND WAS UNABLE TO MOVE UP AND DOWN. THE TUBE WAS UNAFFECTED AND HAD NO TRACES OF DAMAGE OR DEFORMITY. THE PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451175 ↗