aScope™ 3 Regular 5.0/2.2Flexible Videoscope - Single Use 403001000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480121991), received between Jan 7, 2021 and Jun 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionJun 15, 2021Difficult to Remove; Material Twisted/Bent; Positioning Problem

  DURING AN EMERGENCY BRONCHIAL FIBROSCOPY IN A (B)(6) YEAR-OLD PATIENT THE DISTAL END OF THE ASCOPE 3 LOCKED IN A BENT POSITION. IT WAS IMPOSSIBLE TO PUT IT BACK IN UPRIGHT POSITION. PATIENT OUTCOME WAS NOT AFFECTED. HOWEVER, THE EXAMINATION WAS INTERRUPTED BECAUSE THE ASCOPE WAS DIFFICULT TO DIRECT. EXTRACTION OF THE FIBERSCOPE FROM THE INTUBATION TUBE WAS COMPLICATED. THERE WAS A RISK OF EXTUBATION OF THE PATIENT DURING THE EXTRACTION OF THE FIBERSCOPE. NO HARM WAS CAUSED TO THIS PATIENT, HOWEVER, WERE THIS FAULT TO RECUR IT WOULD POSE A RISK OF CAUSING SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998704 ↗
• MalfunctionJan 7, 2021Material Twisted/Bent

  DURING AN EMERGENCY BRONCHIAL FIBROSCOPY IN A 10-YEAR-OLD PATIENT THE DISTAL END OF THE ASCOPE 3 LOCKED IN A BENT POSITION. IT WAS IMPOSSIBLE TO PUT IT BACK IN UPRIGHT POSITION. PATIENT OUTCOME WAS NOT AFFECTED. HOWEVER, THE EXAMINATION WAS INTERUPTED BECAUSE THE ASCOPE WAS DIFFICULT TO DIRECT. EXTRACTION OF THE FIBERSCOPE FROM THE INTUBATION TUBE WAS COMPLICATED. THERE WAS A RISK OF EXTUBATION OF THE PATIENT DURING THE EXTRACTION OF THE FIBERSCOPE. NO HARM WAS CAUSED TO THIS PATIENT, HOWEVER, WERE THIS FAULT TO RECCUR IT WOULD POSE A RISK OF CAUSING SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11130877 ↗