aScope™ 4 Broncho Large Sampler Set 5.8/2.8 478501000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05707480146017), received between Dec 30, 2024 and Sep 16, 2025 — classified as 4 injuries.

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

• InjurySep 16, 2025Suction Failure; Suction Failure

  THE ASCOPE DID NOT SUCTION DURING USE. THIS MALFUNCTION CAUSED A DELAY IN RESOLVING ATELECTASIS IN A PATIENT. TO CONTINUE CARING FOR THE PATIENT, THE MEDICAL TEAM HAD TO URGENTLY REPLACE THE FIBERSCOPE WITH ANOTHER DEVICE OF THE SAME MODEL AND LOT, WHICH WORKED PROPERLY. ADDITIONAL INFORMATION RECEIVED ON 18AUG2025: DURING A BRONCHIAL CLEARANCE FIBROSCOPY, THE FIBROSCOPY EQUIPMENT STOPPED SUCTIONING. A COMPLETE CHECK OF THE SUCTION LINE WAS CARRIED OUT, WITHOUT REVEALING ANY UPSTREAM FAILURE. THE PATIENT, ALREADY EXPERIENCING DESATURATION, REQUIRED A CHANGE OF FIBROSCOPE. A DEVICE FROM THE SAME BATCH WAS THEN USED AND FUNCTIONED CORRECTLY. HOWEVER, THIS INCIDENT LED TO A TEMPORARY WORSENING OF DESATURATION, AS WELL AS A DELAY IN CLEARING THE OBSTRUCTION IN A PATIENT WITH ACUTE LOBAR PNEUMONIA.

  Patient problems: Hypoxia

  MAUDE report 23064060 ↗
• InjurySep 16, 2025Suction Failure; Suction Failure

  THE ASCOPE DID NOT SUCTION DURING USE. THIS MALFUNCTION CAUSED A DELAY IN RESOLVING ATELECTASIS IN A PATIENT. TO CONTINUE CARING FOR THE PATIENT, THE MEDICAL TEAM HAD TO URGENTLY REPLACE THE FIBERSCOPE WITH ANOTHER DEVICE OF THE SAME MODEL AND LOT, WHICH WORKED PROPERLY. ADDITIONAL INFORMATION RECEIVED ON 18AUG2025: DURING A BRONCHIAL CLEARANCE FIBROSCOPY, THE FIBROSCOPY EQUIPMENT STOPPED SUCTIONING. A COMPLETE CHECK OF THE SUCTION LINE WAS CARRIED OUT, WITHOUT REVEALING ANY UPSTREAM FAILURE. THE PATIENT, ALREADY EXPERIENCING DESATURATION, REQUIRED A CHANGE OF FIBROSCOPE. A DEVICE FROM THE SAME BATCH WAS THEN USED AND FUNCTIONED CORRECTLY. HOWEVER, THIS INCIDENT LED TO A TEMPORARY WORSENING OF DESATURATION, AS WELL AS A DELAY IN CLEARING THE OBSTRUCTION IN A PATIENT WITH ACUTE LOBAR PNEUMONIA.

  Patient problems: Hypoxia

  MAUDE report 23060420 ↗
• InjuryDec 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED, THAT WHILE PERFORMING AN ALVEOLAR LAVAGE DURING BRONCHIAL FIBROSCOPY, RUBBER OCCLUSIVE MEMBRANE OF THE FIBERSCOPE'S OPERATING CHANNEL RUPTURED AND PART OF IT FELL INTO PATIENT'S BRONCHIAL TREE. THEY WERE NOT ABLE TO RECOVER IT. PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT FOR RESPIRATORY DISTRESS AND UNDERGONE FIBRESCOPY ON THE SAME DAY. PATIENT CONTINUED TO BE HOSPITALIZED IN INTENSIVE CARE AND ACTIONS WERE TAKEN IN THE HOSPITAL TO MANAGE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21047001 ↗
• InjuryDec 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED, THAT WHILE PERFORMING AN ALVEOLAR LAVAGE DURING BRONCHIAL FIBROSCOPY, RUBBER OCCLUSIVE MEMBRANE OF THE FIBERSCOPE'S OPERATING CHANNEL RUPTURED AND PART OF IT FELL INTO PATIENT'S BRONCHIAL TREE. THEY WERE NOT ABLE TO RECOVER IT. PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT FOR RESPIRATORY DISTRESS AND UNDERGONE FIBRESCOPY ON THE SAME DAY. PATIENT CONTINUED TO BE HOSPITALIZED IN INTENSIVE CARE AND ACTIONS WERE TAKEN IN THE HOSPITAL TO MANAGE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21033956 ↗