n.a. 091361-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04048551422519), received between Jun 13, 2023 and Sep 17, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809170 ↗
• MalfunctionMar 11, 2026Material Separation

  IT WAS REPORTED: CCOPE HAD SHAFT SEPARATION DURING PROCEDURE AND DISTAL TIP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569347 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE SCOPE DETACHED AT THE DEFLECTION POINT DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561356 ↗
• InjuryJul 1, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING PROCEDURE WHILE INTUBATING THE PATIENT USING THE FIVE S, THEY DEFLECTED THE SCOPE AND COULDN'T PUT IT BACK IN THE RIGHT POSITION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. FURTHER INFORMATION HAS BEEN RECEIVED ON JUNE 24, 2025. THE FOLLOWING WAS REPORTED: DURING THE PROCEDURE, AFTER SUCCESSFUL ENTRY INTO THE TRACHEA WITH THE BRONCHOSCOPE AND ADVANCING THE ENDOTRACHEAL TUBE OVER IT, WE ATTEMPTED TO WITHDRAW THE BRONCHOSCOPE FROM THE ETT (ENDOTRACHEAL TUBE). UNFORTUNATELY, WE WERE UNABLE TO DO SO. DESPITE MULTIPLE ATTEMPTS AND MANIPULATION OF THE CONTROL LEVER IN BOTH UPWARD, DOWNWARD, AND NEUTRAL POSITIONS, THE BRONCHOSCOPE REMAINED LOCKED IN A FIXED CURVED CONFIGURATION. THIS CREATED A HIGHLY CHALLENGING SITUATION. AFTER SEVERAL FORCEFUL ATTEMPTS, WE WERE EVENTUALLY ABLE TO REMOVE THE ENTIRE UNIT, BRONCHOSCOPE AND ETT TOGETHER WITHOUT CAUSING HARM TO THE PATIENT. HOWEVER, THIS NECESSITATED THE EXTUBATION OF A DIFFICULT AIRWAY, AND WE HAD TO REINTUBATE THE PATIENT USING AN ALTERNATIVE APPROACH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, DUE TO THE REPORTED UNPLANNED REINTUBATION, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373479 ↗
• InjuryJul 1, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING PROCEDURE WHILE INTUBATING THE PATIENT USING THE FIVE S, THEY DEFLECTED THE SCOPE AND COULDN'T PUT IT BACK IN THE RIGHT POSITION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. FURTHER INFORMATION HAS BEEN RECEIVED ON JUNE 24, 2025. THE FOLLOWING WAS REPORTED: DURING THE PROCEDURE, AFTER SUCCESSFUL ENTRY INTO THE TRACHEA WITH THE BRONCHOSCOPE AND ADVANCING THE ENDOTRACHEAL TUBE OVER IT, WE ATTEMPTED TO WITHDRAW THE BRONCHOSCOPE FROM THE ETT (ENDOTRACHEAL TUBE). UNFORTUNATELY, WE WERE UNABLE TO DO SO. DESPITE MULTIPLE ATTEMPTS AND MANIPULATION OF THE CONTROL LEVER IN BOTH UPWARD, DOWNWARD, AND NEUTRAL POSITIONS, THE BRONCHOSCOPE REMAINED LOCKED IN A FIXED CURVED CONFIGURATION. THIS CREATED A HIGHLY CHALLENGING SITUATION. AFTER SEVERAL FORCEFUL ATTEMPTS, WE WERE EVENTUALLY ABLE TO REMOVE THE ENTIRE UNIT, BRONCHOSCOPE AND ETT TOGETHER WITHOUT CAUSING HARM TO THE PATIENT. HOWEVER, THIS NECESSITATED THE EXTUBATION OF A DIFFICULT AIRWAY, AND WE HAD TO REINTUBATE THE PATIENT USING AN ALTERNATIVE APPROACH. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. HOWEVER, DUE TO THE REPORTED UNPLANNED REINTUBATION, THIS CASE IS DEEMED REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373477 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT DURING DOUBLE-LUMEN PLACEMENT PROCEDURE ON (B)(6) 2024, THE DISTAL TIP OF THE SCOPE BROKE. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP STETHOSCOPE.

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

  MAUDE report 19697788 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT DURING DOUBLE-LUMEN PLACEMENT PROCEDURE ON JUNE-6-2024, THE DISTAL TIP OF THE SCOPE BROKE. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP STETHOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697780 ↗
• MalfunctionMar 18, 2024No Display/Image; Optical Distortion; No Display/Image; Optical Distortion

  IT WAS REPORTED ON FEBURARY 27, 2023 THAT :DURING A VETERINARY INTERVENTION, IMAGE FAILURE 5 MINUTES INTO THE PROCEDURE. NO HARM TO PATIENT, USER OR THIRD PARTIES. FURTHER INFORMATION RECEIVED ON THE MARCH 14, 2024 THAT THE BRONCHOSCOPY HAD TO BE ABORTED AND THE LUNG WASH WAS PERFORMED BLIND. DUE TO THE ADDITIONAL INFORMATION AND THE MENTIONED CHANGE OF THE SURGICAL PROCEDURE, THE RISK FOR SERIOUS DETERIORATION IN STATE OF HEALTH IS NOT NEGLIGIBLE. THUS, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926516 ↗
• InjuryJun 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SCOPE WAS USED FOR AN AWAKE FIBRE-OPTIC INTUBATION THE CAMERA TIP BROKE OFF AND WENT MISSING DURING BRONCHOSCOPY. THE BRONCHOSCOPE WAS ALREADY IN THE TRACHEA, BUT THE ET TUBE STRUGGLED TO RAILROAD THROUGH THE MASS LESION AT THE VOCAL CORDS. THE SCOPE WAS PULLED BACK TO CONFIRM THE POSITION OF THE ET TUBE, BUT THE PICTURE WENT BLURRY AND DID NOT CLEAR WITH SUCTIONING. THE PATIENT STARTED TO DESATURATE. THE SCOPE WAS RETRACTED, AND THE VENTILATION WAS INITIATED. THE SCOPE WAS CHECKED FOR COMPLETENESS, AND IT WAS DISCOVERED THAT THE CAMERA TIP WAS ABSENT. AFTER THE PROCEDURE, THE TIP WAS FOUND ON THE FLOOR. THE INTUBATION WAS UNSUCCESSFULLY, AND A TRACHEOSTOMY NEEDS TO BE PERFORMED. THE CAUSE OF THE TRACHEOSTOMY IS UNKNOWN, BUT DUE TO THE STEPS TAKEN AND THE ADDITIONAL TREATMENT, THIS CASE WAS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 17117788 ↗
• InjuryJun 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE SCOPE WAS USED FOR AN AWAKE FIBRE-OPTIC INTUBATION THE CAMERA TIP BROKE OFF AND WENT MISSING DURING BRONCHOSCOPY. THE BRONCHOSCOPE WAS ALREADY IN THE TRACHEA, BUT THE ET TUBE STRUGGLED TO RAILROAD THROUGH THE MASS LESION AT THE VOCAL CORDS. THE SCOPE WAS PULLED BACK TO CONFIRM THE POSITION OF THE ET TUBE, BUT THE PICTURE WENT BLURRY AND DID NOT CLEAR WITH SUCTIONING. THE PATIENT STARTED TO DESATURATE. THE SCOPE WAS RETRACTED, AND THE VENTILATION WAS INITIATED. THE SCOPE WAS CHECKED FOR COMPLETENESS, AND IT WAS DISCOVERED THAT THE CAMERA TIP WAS ABSENT. AFTER THE PROCEDURE, THE TIP WAS FOUND ON THE FLOOR. THE INTUBATION WAS UNSUCCESSFULLY, AND A TRACHEOSTOMY NEEDS TO BE PERFORMED. THE CAUSE OF THE TRACHEOSTOMY IS UNKNOWN, BUT DUE TO THE STEPS TAKEN AND THE ADDITIONAL TREATMENT, THIS CASE WAS DEEMED REPORTABLE.

  Patient problems: Insufficient Information

  MAUDE report 17117787 ↗