N/A 0915612-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04048551446690), received between Dec 4, 2024 and Apr 3, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jul 7, 2023Open, Classified

   Flexible intubation endoscopes sterility assurance can not be confirmed.

   Z-2589-2023 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Optical Problem

  IT WAS REPORTED THAT THE PATIENT ASPIRATES AND HER PULMONARY CONDITION DETERIORATE. GIVEN THE OVERALL SITUATION, INTUBATION SHOULD BE AVOIDED IF POSSIBLE; THEREFORE, THE DECISION IS MADE TO PERFORM BRONCHOSCOPY UNDER SEDATION VIA THE NASAL ROUTE. THE ENDOSCOPE BECOMES BLOCKED SEVERAL TIMES DUE TO VERY THICK SECRETIONS AND MUST BE FLUSHED REPEATEDLY OUTSIDE THE PATIENT. AFTER APPROXIMATELY THE THIRD TIME, THE COLD LIGHT ILLUMINATION AT THE FRONT OF THE BRONCHOSCOPE FAILS. THE IMAGE FROM THE CAMERA IS STILL VISIBLE ON THE MONITOR UNDER ROOM LIGHTING, BUT AS SOON AS THE SCOPE IS INSERTED INTO THE NOSTRIL, VISIBILITY IS LOST BECAUSE THERE IS NO LIGHT. THE BRONCHOSCOPY MUST BE DISCONTINUED. THE PATIENT WAS REINTUBATED FOLLOWING FURTHER PULMONARY DETERIORATION; HOWEVER, THIS WOULD LIKELY HAVE BEEN NECESSARY EVEN IF THE BRONCHOSCOPY HAD BEEN SUCCESSFUL. DUE TO DISCONTINUATION OF BRONCHOSCOPY AND REINTUBATION, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779697 ↗
• InjuryDec 4, 2024Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN INSERTING THE INTUBATION VIDEO ENDOSCOPE INTO THE TUBE, STREAKS IN THE IMAGE DISPLAY ON THE C-MAC MONITOR AND IMAGE DROPOUTS OCCURRED. PROCEDURE WAS NOT COMPLETED AND BRONCHOSCOPY DELAYED, A SECOND BRONCHOSCOPE HAD TO BE ORGANIZED TO FINISH THE BRONCHEOALVEOLAR LAVAGE.

  Patient problems: Insufficient Information

  MAUDE report 20844551 ↗
• MalfunctionDec 4, 2024Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN INSERTING THE INTUBATION VIDEO ENDOSCOPE INTO THE TUBE, STREAKS IN THE IMAGE DISPLAY ON THE C-MAC MONITOR AND IMAGE DROPOUTS OCCURRED. PROCEDURE WAS NOT COMPLETED AND BRONCHOSCOPY DELAYED, A SECOND BRONCHOSCOPE HAD TO BE ORGANIZED TO FINISH THE BRONCHEOALVEOLAR LAVAGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844516 ↗