aScope™ 4 Broncho Slim 3.8/1.2 476001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05707480135479), received between Sep 4, 2019 and Feb 1, 2023 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Mechanical Problem; Mechanical Problem

  DURING PROCEDURE THE TIP OF THE SCOPE GOT STUCK IN THE HUB OF A DOUBLE LUMEN TUBE. THE ANESTHESIOLOGIST WAS UNABLE TO MOVE THE SCOPE OR PULL IT OUT IN ORDER TO VENTILATE THE PATIENT. THE TIP OF THE SCOPE BROKE IN THE DLT. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16279594 ↗
• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING PROCEDURE THE TIP OF THE SCOPE GOT STUCK IN THE HUB OF A DOUBLE LUMEN TUBE. ANESTHESIOLOGIST WAS UNABLE TO MOVE THE SCOPE OR PULL IT OUT IN ORDER TO VENTILATE THE PATIENT. THE TIP OF THE SCOPE BROKE IN THE DLT. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276618 ↗
• InjurySep 8, 2022Use of Device Problem; Use of Device Problem

  WHILE ATTEMPTING TO CONFIRM PROPER POSITIONING OF A DOUBLE LUMEN ENDOTRACHEAL TUBE WITH A DISPOSABLE BRONCHOSCOPE, IT WAS NOTED BRONCHOSCOPE APPEARED TO BE STUCK WHILE THROUGH ETT. THE BRONCHOSCOPE WAS INSERTED SLIGHTLY FURTHER AND THEN PULLED BACK. THERE WAS A LOSS OF RESISTANCE BUT ON WITHDRAWAL IT WAS NOTED THE SCOPE WAS BROKEN WITH EXPOSED WIRES. A NEW BRONCHOSCOPE WAS INSERTED AND THE DISTAL TIP OF PREVIOUS BROKEN BRONCHOSCOPE WAS FOUND IN RIGHT MIDDLE LOBE BRONCHUS. PROCEDURE WAS PROCEEDED. AT THE END THE SURGEON WENT IN WITH FORCEPS AND REMOVED THE BROKEN TIP EASILY. THERE WAS NO SIGN OF TRAUMA OF ANY SORT TO THE AIRWAY, AND THE PIECE CAME OUT WITHOUT RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382135 ↗
• MalfunctionSep 8, 2022Use of Device Problem; Use of Device Problem

  WHILE ATTEMPTING TO CONFIRM PROPER POSITIONING OF A DOUBLE LUMEN ENDOTRACHEAL TUBE WITH A DISPOSABLE BRONCHOSCOPE, IT WAS NOTED BRONCHOSCOPE APPEARED TO BE STUCK WHILE THROUGH ETT. WHILE ATTEMPTING TO CONFIRM PROPER POSITIONING OF A DOUBLE LUMEN ENDOTRACHEAL TUBE WITH A DISPOSABLE BRONCHOSCOPE, IT WAS NOTED BRONCHOSCOPE APPEARED TO BE STUCK WHILE THROUGH ETT. THE BRONCHOSCOPE WAS INSERTED SLIGHTLY FURTHER AND THEN PULLED BACK. THERE WAS A LOSS OF RESISTANCE BUT ON WITHDRAWAL IT WAS NOTED THE SCOPE WAS BROKEN WITH EXPOSED WIRES. A NEW BRONCHOSCOPE WAS INSERTED AND THE DISTAL TIP OF PREVIOUS BROKEN BRONCHOSCOPE WAS FOUND IN RIGHT MIDDLE LOBE BRONCHUS. PROCEDURE WAS PROCEEDED. AT THE END THE SURGEON WENT IN WITH FORCEPS AND REMOVED THE BROKEN TIP EASILY. THERE WAS NO SIGN OF TRAUMA OF ANY SORT TO THE AIRWAY, AND THE PIECE CAME OUT WITHOUT RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15376512 ↗
• MalfunctionJul 7, 2022Break; Mechanical Jam

  JAMMING OF THE TIP EXTENDER RESULTING IN FRACTURE OF TIP WITHIN THE ENDOTRACHEAL TUBE. THE THUMB OPERATED TIP FLEXOR/EXTENDER BECAME JAMMED IN HYPER ACUTE FLEXION POSITION. IT WAS THEN IMPOSSIBLE TO EXTRACT THE SCOPE CONVENTIONALLY. WHEN A LITTLE FIRM PRESSURE WAS APPLIED TO EXTRACT THE SCOPE, THE DEVICE FRACTURED AT THE LEVEL OF THE TIP, WITH THE TIP REMAINING AT THE BIFURCATION OF THE ENDOTRACHEAL TUBE. THE ENTIRE TIP WAS REMOVED AT THE END OF THE CASE INTACT AFTER EXTUBATION. THE PATIENT WAS UNHARMED BUT THE DOUBLE LUMEN TUBE WAS COMPROMISED AND AN ADDITIONAL UNEVENTFUL BRONCHOSCOPY WAS PERFORMED AT THE END OF THE CASE TO VERIFY THAT THERE WAS NO FOREIGN BODY IN THE DISTAL BRONCHI. PATIENT OUTCOME NOT AFFECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14948915 ↗
• MalfunctionJul 6, 2022Mechanical Jam; Mechanical Jam

  THE DATE OF THE EVENT HAS NOT BEEN REPORTED. JAMMING OF THE TIP EXTENDER RESULTING IN FRACTURE OF TIP WITHIN THE ENDOTRACHEAL TUBE. THE THUMB OPERATED TIP FLEXOR/EXTENDER BECAME JAMMED IN HYPER ACUTE FLEXION POSITION. IT WAS IMPOSSIBLE TO EXTRACT THE SCOPE CONVENTIONALLY. WHEN A LITTLE FIRM PRESSURE WAS APPLIED TO EXTRACT THE SCOPE THE DEVICE FRACTURED AT THE LEVEL OF THE TIP, WITH THE TIP REMAINING AT THE BIFURCATION OF THE ENDOTRACHEAL TUBE. THE ENTIRE TIP WAS REMOVED AT THE END OF THE CASE INTACT AFTER EXTUBATION. THE PATIENT WAS UNHARMED BUT THE DOUBLE LUMEN TUBE WAS COMPROMISED AND AN ADDITIONAL UNEVENTFUL BRONCHOSCOPY WAS PERFORMED AT THE END OF THE CASE TO VERIFY THAT THERE WAS NO FOREIGN BODY IN THE DISTAL BRONCHI. PATIENT OUTCOME NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14927574 ↗
• InjuryMar 2, 2022Material Separation

  A TINY RIM OF PLASTIC WHICH FITS THE RIM AND DIAMETER OF SCOPE WAS FOUND IN THE PATIENT'S AIRWAYS AND WAS RETRIEVED FROM THE LUNGS DURING THE BRONCHOSCOPY. LEFT MAIN BRONCHUS TUBE WAS REMOVED, A RIGID AND FLEXIBLE BRONCHOSCOPY WAS PERFORMED AND 4MM PLASTIC WAS LOCATED AND TAKEN OUT USING FLEXIBLE BIOPSY FORCEPS. THE HEALTH CARE PROFESSIONAL ASSUMED THAT THE PLASTIC PIECE CAME FROM THE TUBE OF ANOTHER DEVICE AND ENTERED THE PATIENTS LUNGS. THE PATIENT WAS NOT HARMED, BUT THE PROCEDURE WAS SIGNIFICANTLY PROLONGED. NO SPECIFIC EVENT DAY WAS PROVIDED HOWEVER, IT IS STATED THAT THE EVENT OCCURED DURING (B)(6) 2021.

  Patient problems: Foreign Body In Patient

  MAUDE report 13654219 ↗
• InjuryMar 1, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A TINY RIM OF PLASTIC WHICH FITS THE RIM AND DIAMETER OF SCOPE WAS FOUND IN THE PATIENT'S AIRWAYS AND WAS RETRIEVED FROM THE LUNGS DURING THE BRONCHOSCOPY. LEFT MAIN BRONCHUS TUBE WAS REMOVED, A RIGID AND FLEXIBLE BRONCHOSCOPY WAS PERFORMED AND 4MM PLASTIC WAS LOCATED AND TAKEN OUT USING FLEXIBLE BIOPSY FORCEPS. THE HEALTH CARE PROFESSIONAL ASSUMED THAT THE PLASTIC PIECE CAME FROM THE TUBE OF ANOTHER DEVICE AND ENTERED THE PATIENTS LUNGS. THE PATIENT WAS NOT HARMED, BUT THE PROCEDURE WAS SIGNIFICANTLY PROLONGED. USING THE PRINCIPLE WHEN IN DOUBT REPORT, WE HAVE DECIDED TO REPORT THIS INCIDENT. NO SPECIFIC EVENT DAY WAS PROVIDED HOWEVER, IT IS STATED THAT THE EVENT OCCURED DURING (B)(6) 2021.

  Patient problems: Foreign Body In Patient

  MAUDE report 13635822 ↗
• MalfunctionJul 5, 2021Break

  A ASCOPE 4 BRONCHO SLIM WAS USED TO CHECK THE PLACEMENT OF THE DLT. DURING THE MANIPULATION THEY EXPERIENCED A LOSS OF VISION, AND BY REMOVAL OF THE ASCOPE 4 BRONCHO SLIM IT WAS DISCOVERED THAT THE DISTAL TIP HAD DISENGAGED. THE OPERATORS USED A SECOND ASCOPE 4 BRONCHO SLIM TO CONFIRM THE PLACEMENT OF THE DLT. AT THE END OF THE PROCEDURE, THE PATIENT WAS EXTUBATED AND USING A REUSABLE FIBERSCOPE THEY PERFORMED A NEW EXPLORATION OF THE BRONCHI (ON BOTH SIDES). THE TIP WAS NOT FOUND. POST-OPERATIVE RADIOLOGICAL AND SCANNOGRAPHIC CHECKS SHOWED NO FOREIGN BODY OR VENTILATION DISORDERS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12115429 ↗
• InjuryJun 4, 2021Break

  THE TIP OF AN AMBU ASCOPE 4 BRONCHO SLIM 3.8/1.2 SINGLE-USE AND FLEXIBLE BRONCHOSCOPE BROKE OFF INSIDE THE ENDOTRACHEAL AIRWAY TUBE OF A PATIENT. THE BROKEN OFF PIECE WAS RETRIEVED BY THE PHYSICIAN. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940882 ↗
• InjuryMay 19, 2021Break

  THE TIP OF AN AMBU ASCOPE 4 BRONCHO SLIM 3.8/1.2 SINGLE-USE AND FLEXIBLE BRONCHOSCOPE BROKE OFF INSIDE THE ENDOTRACHEAL AIRWAY TUBE OF A PATIENT. THE BROKEN OFF PIECE WAS RETRIEVED BY THE PHYSICIAN. PATIENT OUTCOME WAS NOT AFFECTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11848431 ↗
• InjurySep 4, 2019Detachment of Device or Device Component

  AN ASCOPE 4 BRONCHO SLIM WAS USED TO CHECK THE PLACEMENT OF THE DLT. DURING THE MANIPULATION THEY EXPERIENCED A LOSS OF VISION, AND BY REMOVAL OF THE ASCOPE 4 BRONCHO SLIM IT WAS DISCOVERED THAT THE DISTAL TIP HAD DISENGAGED. THE OPERATORS USED A SECOND ASCOPE 4 BRONCHO SLIM TO CONFIRM THE PLACEMENT OF THE DLT. AT THE END OF THE PROCEDURE, THE PATIENT WAS EXTUBATED AND USING A REUSABLE FIBERSCOPE THEY PERFORMED A NEW EXPLORATION OF THE BRONCHI (ON BOTH SIDES). THE TIP WAS NOT FOUND. POST-OPERATIVE RADIOLOGICAL AND SCANNOGRAPHIC CHECKS SHOWED NO FOREIGN BODY OR VENTILATION DISORDERS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8960744 ↗