aScope™ 4 Broncho Large 5.8/2.8 478001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05707480135530), received between Jun 4, 2021 and Sep 2, 2026 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2026Detachment of Device or Device Component

  During a bronchoscopy procedure using an aScope 4 Broncho Large 5.8/2.8, the distal tip of the device detached. A second bronchoscopy was performed using a reusable bronchoscope to retrieve the detached part with biopsy forceps. The involved device has been retained by the hospital for investigation if required. Patient outcome: Examination prolonged, with no serious consequences for the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570454 ↗
• InjurySep 2, 2026Detachment of Device or Device Component

  During a bronchoscopy procedure using an aScope 4 Broncho Large 5.8/2.8, the distal tip of the device detached. A second bronchoscopy was performed using a reusable bronchoscope to retrieve the detached part with biopsy forceps. The involved device has been retained by the hospital for investigation if required. Patient outcome: Examination prolonged, with no serious consequences for the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564938 ↗
• InjuryAug 7, 2026Detachment of Device or Device Component

  According to the reported customer complaint:Parts of the bronchoscope have come loose inside the tube. The client informed us by email; sales rep contacted them by phone.The bronchoscope will be picked up on Monday, and sales rep will speak with the senior physician in person. The patient was intubated with an 8.0 tube and then underwent bronchoscopy. During the procedure, the thoracic surgeon noticed that the bronchoscope "got stuck" in the tube. Upon withdrawing it, the thoracic surgeon discovered that the tip was still lodged in the tube. The patient was then reintubated; he was not harmed.The materials were forwarded to the purchasing department. The bronchoscope was inserted via a duckbill cuff with integrated suction and broke off inside the tube during the procedure. Fortunately, the patient was not harmed. The incident was detected due to unstable ventilation, allowing the patient to be reintubated immediately.

  Patient problems: Unintended Extubation

  MAUDE report 50174412 ↗
• InjuryAug 7, 2026Detachment of Device or Device Component

  According to the reported customer complaint: Parts of the bronchoscope have come loose inside the tube. The client informed us by email; sales rep contacted them by phone. The bronchoscope will be picked up on Monday, and sales rep will speak with the senior physician in person. The patient was intubated with an 8.0 tube and then underwent bronchoscopy. During the procedure, the thoracic surgeon noticed that the bronchoscope "got stuck" in the tube. Upon withdrawing it, the thoracic surgeon discovered that the tip was still lodged in the tube. The patient was then reintubated; he was not harmed.The materials were forwarded to the purchasing department. The bronchoscope was inserted via a duckbill cuff with integrated suction and broke off inside the tube during the procedure. Fortunately, the patient was not harmed. The incident was detected due to unstable ventilation, allowing the patient to be reintubated immediately.

  Patient problems: Unintended Extubation

  MAUDE report 50172087 ↗
• InjuryFeb 10, 2026Detachment of Device or Device Component

  AS PER THE CUSTOMER, PATIENT WAS ENDOSCOPED FEW TIMES ON THIS OCCASION THERE WAS A PIECE OF PLASTIC IN PATIENTS BRONCHUS WHICH THEY REMOVED, IT LOOKED LIKE A PIECE OF OUR SCOPE. THE DOCTOR DISCOVERED A WHITE CIRCULAR PIECE OF PLASTIC IN PATIENT`S TRACHEA WHEN HE WAS DOING A FOLLOW-UP BRONCHOSCOPY, SAME SCOPE HAD BEEN USED ON THE SAME PATIENT FEW HOURS BEFORE. THE PIECE OF PLASTIC WAS WHITE AND LOOKED LIKE A PIECE FROM THE END OF THE SCOPE. UNFORTUNATELY THE SCOPE AS WELL AS THE PIECE WAS THROWN AWAY AND CUSTOMER DOES NOT KNOW THE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309430 ↗
• InjuryFeb 10, 2026Detachment of Device or Device Component

  AS PER THE CUSTOMER, PATIENT WAS ENDOSCOPED FEW TIMES ON THIS OCCASION THERE WAS A PIECE OF PLASTIC IN PATIENTS' BRONCHUS WHICH THEY REMOVED, IT LOOKED LIKE A PIECE OF OUR SCOPE. THE DOCTOR DISCOVERED A WHITE CIRCULAR PIECE OF PLASTIC IN PATIENT`S TRACHEA WHEN HE WAS DOING A FOLLOW-UP BRONCHOSCOPY, SAME SCOPE HAD BEEN USED ON THE SAME PATIENT FEW HOURS BEFORE. PIECE OF PLASTIC WAS WHITE AND LOOKED LIKE PIECE FROM THE END OF THE SCOPE. UNFORTUNATELY, SCOPE AS WELL AS THE PIECE WAS THROWN AWAY AND CUSTOMER DOES NOT KNOW THE LOT NUMBER EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301740 ↗
• MalfunctionNov 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  WHILE WITHDRAWING THE BRONCHOSCOPE WITHOUT RESISTANCE, THE DISTAL TIP REMAINED LODGED IN THE ENDOTRACHEAL TUBE. THE INTENSIVE CARE PATIENT SUBSEQUENTLY HAD TO BE REINTUBATED. THE PATIENT WAS DEEPLY SEDATED, DID NOT STRAIN, AND THE BRONCHOSCOPY WAS PERFORMED WITHOUT DIFFICULTY AND WITH GOOD VISIBILITY. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Unintended Extubation

  MAUDE report 23593929 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  WHILE WITHDRAWING THE BRONCHOSCOPE WITHOUT RESISTANCE, THE DISTAL TIP REMAINED LODGED IN THE ENDOTRACHEAL TUBE. THE INTENSIVE CARE PATIENT SUBSEQUENTLY HAD TO BE REINTUBATED. THE PATIENT WAS DEEPLY SEDATED, DID NOT STRAIN, AND THE BRONCHOSCOPY WAS PERFORMED WITHOUT DIFFICULTY AND WITH GOOD VISIBILITY. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Unintended Extubation

  MAUDE report 23579167 ↗
• MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A BRONCHOSCOPY FOR SECRETION RETENTION, THE DISTAL END OF THE BRONCHOSCOPE WAS TORN OFF. THE ENDOSCOPE WAS DISPOSED OF. ONLY THE DISTAL END WAS RETAINED AND WILL BE SENT IN. PATIENT OUTCOME NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533586 ↗
• MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A BRONCHOSCOPY FOR SECRETION RETENTION, THE DISTAL END OF THE BRONCHOSCOPE WAS TORN OFF. THE ENDOSCOPE WAS DISPOSED OF. ONLY THE DISTAL END WAS RETAINED AND WILL BE SENT IN. PATIENT OUTCOME NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531395 ↗
• InjuryAug 18, 2022Break; Mechanical Problem; Mechanical Problem

  AN ASCOPE 4 BRONCHO LARGE WAS USED ON PATIENT WITH A SIZE 7.5 MM INTUBATION TUBE. THE DISTAL END OF THE BRONCHOSCOPE BROKE OFF DURING REMOVAL OF THE SCOPE. THE BROKEN OFF PIECE HAD TO BE REMOVED FROM THE PATIENTS LUNG. PATIENT OUTCOME WAS NOT AFFECTED BY THE INCIDENT AS THE PIECE WAS SUCCESFULLY RETRIEVED BY THE PULMONOLOGISTS ON AN EMERGENCY BASIS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15253271 ↗
• MalfunctionAug 18, 2022Mechanical Jam; Mechanical Jam

  AN ASCOPE 4 BRONCHO LARGE WAS USED ON PATIENT WITH A SIZE 7.5 MM INTUBATION TUBE. THE DISTAL END OF THE BRONCHOSCOPE BROKE OFF DURING REMOVAL OF THE SCOPE. THE BROKEN OFF PIECE HAD TO BE REMOVED FROM THE PATIENTS LUNG. PATIENT OUTCOME WAS NOT AFFECTED BY THE INCIDENT AS THE PIECE WAS SUCCESFULLY RETRIEVED BY THE PULMONOLOGISTS ON AN EMERGENCY BASIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15247249 ↗
• MalfunctionJan 12, 2022Break; Entrapment of Device

  AN ASCOPE 4 BRONCHO WAS USED IN COMBINATION WITH A SHILEY EVAC ORAL TRACHEAL TUBE. WHEN THE ASCOPE 4 BRONCHO LARGE WAS PULLED OUT, THE TIP OF THE BRONCHOSCOPE TEARED OFF. THE BENDING PIECE GOT STUCK IN THE TUBE AND CAUSED AN AIRWAY OBSTRUCTION. THE USER HAS CONFIRMED THAT THE TRACHEAL TUBE WAS BENT DURING THE PROCEDURE.

  Patient problems: Airway Obstruction; Foreign Body In Patient

  MAUDE report 13238803 ↗
• MalfunctionJan 11, 2022Material Fragmentation; Material Fragmentation

  AN ASCOPE 4 BRONCHO WAS USED IN COMBINATION WITH A SHILEY EVAC ORAL TRACHEAL TUBE. WHEN THE ASCOPE 4 BRONCHO LARGE WAS PULLED OUT, THE TIP OF THE BRONCHOSCOPE TEARED OFF. THE BENDING PIECE GOT STUCK IN THE TUBE AND CAUSED AN AIRWAY OBSTRUCTION. THE USER HAS CONFIRMED THAT THE TRACHEAL TUBE WAS BENT DURING THE PROCEDURE.

  Patient problems: Airway Obstruction

  MAUDE report 13225304 ↗
• InjurySep 3, 2021Physical Resistance/Sticking

  AMBU BRONCHOSCOPE SIZE LARGE BECAME STUCK ON XLT DISTAL TRACHEOSTOMY DISPOSABLE INNER CANNULA DURING BRONCHOSCOPY. IT WAS REPORTED THAT THE BRONCHOSCOPE GOT STUCK DURING BRONCHOSCOPY ON THE INNER CANNULA ON XLT DISTAL TRACHEOSTOMY AND THE PATIENT EXPIRED. DURING INVESTIGATION, THE NURSE CLARIFIED THAT THE BRONCHOSCOPE DID NOT CAUSE THE DEATH OF THE PATIENT, AS THE SCOPE WAS SUCCESSFULLY REMOVED WHILE THE PATIENT WAS ALIVE. THE NURSE FURTHER CLARIFIED, THAT IT WAS THE PATIENT'S UNDERLYING CONDITIONS THAT LED TO HIS UNFORTUNATE DEATH. THE DEVICE IS THEREFORE NOT RELATED TO THE DEATH OF THE PATIENT. HOWEVER, THE INCIDENT DID LEAD THE PATIENT TO HAVE AN ANXIETY CARDIAC ARREST.

  Patient problems: Anxiety; Cardiac Arrest

  MAUDE report 12422315 ↗
• InjurySep 1, 2021Entrapment of Device; Entrapment of Device

  AMBU BRONCHOSCOPE SIZE LARGE BECAME STUCK ON XLT DISTAL TRACHEOSTOMY DISPOSABLE INNTER CANNULA DURING BRONCHOSCOPY. IT WAS REPORTED THAT THE BRONCHOSCOPE GOT STUCK DURING BRONCHOSCOPY ON THE INNER CANNULA ON XLT DISTAL TRACHEOSTOMY AND THE PATIENT EXPIRED. DURING INVESTIGATION, THE NURSE CLARIFIED THAT THE BRONCHOSCOPE DID NOT CAUSE THE DEATH OF THE PATIENT, AS THE SCOPE WAS SUCCESSFULLY REMOVED WHILE THE PATIENT WAS ALIVE. THE NURSE FURTHER CLARIFIED, THAT IT WAS THE PATIENT'S MANY OTHER CONDITIONS THAT LED TO HIS UNFORTUNATE DEATH. THE DEVICE IS THEREFORE NOT RELATED TO THE DEATH OF THE PATIENT. HOWEVER, THE INCIDENT DID LEAD THE PATIENT TO HAVE AN ANXIETY CARDIAC ARREST.

  Patient problems: Cardiac Arrest

  MAUDE report 12406198 ↗
• InjuryJul 25, 2021Break

  AN ASCOPE 4 BONCHO LARGE WAS USED ON A PATIENT WITH A SIZE 8 INTUBATION TUBE. THE DISTAL END OF THE BRONCHOSCOPE BROKE OFF DURING REMOVAL OF THE SCOPE. THE BROKEN OFF PIECE HAD TO BE REMOVED FROM THE PATIENT'S AIRWAYS. PATIENT OUTCOME WAS NOT AFFECTED BY THIS INCIDENT AS THE PIECE WAS SUCCESSFULLY RETRIEVED AT BEDSIDE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12222997 ↗
• MalfunctionJul 25, 2021Break; Defective Device

  AN ASCOPE 4 BONCHO LARGE WAS USED ON A PATIENT WITH A SIZE 8 INTUBATION TUBE. THE DISTAL END OF THE BRONCHOSCOPE BROKE OFF DURING REMOVAL OF THE SCOPE. THE BROKEN OFF PIECE HAD TO BE REMOVED FROM THE PATIENT'S AIRWAYS. PATIENT OUTCOME WAS NOT AFFECTED BY THIS INCIDENT AS THE PIECE WAS SUCCESSFULLY RETRIEVED AT BEDSIDE.

  Patient problems: Insufficient Information

  MAUDE report 12222996 ↗
• InjuryJul 6, 2021Break

  DURING A FIBERSCOPY IN THE ICU THE CONTROL LEVER OF AN ASCOPE 4 BRONCHO BROKE. THE HEALTHCARE PROFESSIONALS IMMEDIATELY TRIED ANOTHER ASCOPE 4 BRONCHO FROM THE SAME BATCH, BUT THE CONTROL LEVER OF THAT SCOPE ALSO BROKE. DUE TO THE PROLONGED PROCEDURE, THE PATIENT DESATURATED. THE ENDOSCOPY WAS THEN PERFORMED WITH A FUNCTIONAL ENDOSCOPE. PATIENT SATURATION LEVEL RETURNED TO NORMAL. NO LONG TERM SERIOUS HEALTH DETERIORATION FOR THE PATIENT WERE REPORTED.

  Patient problems: Hypoxia

  MAUDE report 12119768 ↗
• InjuryJun 4, 2021Break

  DURING A FIBERSCOPY IN THE ICU THE CONTROL LEVER OF AN ASCOPE 4 BRONCHO BROKE. THE HEALTHCARE PROFESSIONALS IMMEDIATELY TRIED ANOTHER ASCOPE4 BRONCHO FROM THE SAME BATCH, BUT THE CONTROL LEVER OF THAT SCOPE ALSO BROKE. DUE TO THE PROLONGED PROCEDURE, THE PATIENT DESATURATED. THE ENDOSCOPY WSA THEN PERFORMED WITH A FUNCTIONAL ENDOSCOPE. PATIENT SATURATION LEVEL RETURNED TO NORMAL. NO LONG TERM SERIOUS HEALTH DETERIORATION FOR THE PATIENT WERE REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11940894 ↗