GlideScope® BFlex™ 3.8Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00879123006394), received between Jul 15, 2020 and Oct 11, 2023 — classified as 13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A CUSTOMER REPORTED VIA MEDWATCH REPORT NUMBER MW5144971 THAT DURING A DUAL-LUMEN INTUBATION, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THE END OF THE BRONCHOSCOPE BROKE OFF IN THE PATIENT'S BRONCHUS. ANOTHER SCOPE WAS USED TO RETRIEVE THE BROKEN PIECE WHICH WAS REPORTED AS BEING HOLLOW PLASTIC APPROXIMATELY 4-5 MM IN DIAMETER AND 1.5-2 CM IN LENGTH. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913126 ↗
• MalfunctionJun 8, 2023Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, AFTER INSERTING A 35 FR DOUBLE LUMEN TUBE (DLT) INTO THE PATIENT AND BLOCKING THE CUFF, THEY WERE UNABLE TO PASS THE BRONCHOSCOPE THROUGH THE DLT AT THE POINT OF THE CUFF. IT WAS REPORTED THAT THE USERS REPLACED THE 35 FR DLT WITH A LARGER 37 FR DLT WHICH NO LONGER GAVE THEM ISSUES ADVANCING THE BRONCHOSCOPE. THE 35 FR DLT USED DURING THE PROCEDURE WAS MANUFACTURED BY RÜSCH / TELEFLEX. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090076 ↗
• MalfunctionApr 18, 2023No Display/Image; No Display/Image

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THERE WAS NO IMAGE ON THE MONITOR. THE PROCEDURE WAS COMPLETED USING A BACKUP GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPE WHICH DELAYED THE PROCEDURE BY TEN (10) MINUTES. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762163 ↗
• MalfunctionMar 21, 2023Break; Break

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THE DEVICE BROKE DURING INTUBATION. THE TIP OF THE BRONCHOSCOPE WAS LODGED IN THE ENDOTRACHEAL (ET) TUBE (SHILEY ENDOBRONCHIAL TUBE LEFT, SIZE 39 FR) WHICH WAS SUBSEQUENTLY REPLACED WITH A BACKUP ET TUBE TO COMPLETE THE PROCEDURE. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION RECEIVED UPON FOLLOWING UP WITH THE CUSTOMER REPORTED THAT THE BRONCHOSCOPE WAS BEING RETRACTED FROM THE ET TUBE FOR THE FIRST TIME WHEN THE USER FELT RESISTANCE AND THE BRONCHOSCOPE SUBSEQUENTLY BROKE. THE CUSTOMER REPORTED IT IS UNKNOWN IF THE BRONCHOSCOPE WAS IN A NEUTRAL POSITION WHEN IT WAS BEING RETRACTED AND NO LUBRICATION WAS USED. THE GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPES OPERATIONS & MAINTENANCE MANUAL (OMM) STATES TO LUBRICATE THE SCOPE OR TUBE PRIOR TO INSERTING THE BRONCHOSCOPE INTO THE INTERNAL CHANNEL OF THE TUBE. IF THERE IS ONGOING RESISTANCE, USERS SHOULD CONSIDER APPLYING ADDITIONAL LUBRICATION TO THE SCOPE OR TUBE. FURTHERMORE, THE OMM STATES, "IF YOU ENCOUNTER RESISTANCE DURING WITHDRAWAL, REINSERT THE BRONCHOSCOPE SLIGHTLY, AND THEN GENTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583697 ↗
• MalfunctionFeb 22, 2023Break; Material Deformation

  GLIDESCOPE BROKE DURING INTUBATION. THE TIP OF THE GLIDESCOPE WAS LODGED IN THE ET TUBE.

  Patient problems: Insufficient Information

  MAUDE report 16416699 ↗
• MalfunctionDec 13, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THE SCREEN WOULD COMPLETELY FREEZE UP WHEN PLACING THE BRONCHOSCOPE IN THE ET TUBE. THEY REPORTED REMOVING THE BRONCHOSCOPE TO GET THE PICTURE BACK, TRIED RE-INSERTING IT, AND IT FROZE AGAIN. THE PROCEDURE WAS COMPLETED USING ANOTHER GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE WHICH WAS MADE AVAILABLE IN AN UNSPECIFIED AMOUNT OF TIME. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970321 ↗
• MalfunctionDec 13, 2022Display or Visual Feedback Problem; No Visual Prompts/Feedback; Display or Visual Feedback Problem; No Visual Prompts/Feedback

  THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THE IMAGE LAGGED AND THEN FROZE WHILE IN USE. THE BRONCHOSCOPE WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970243 ↗
• MalfunctionNov 1, 2022Difficult to Remove; Retraction Problem; Device Damaged by Another Device; Difficult to Remove; Retraction Problem; Device Damaged by Another Device

  A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, WHEN REMOVING THE BRONCHOSCOPE FROM THE DOUBLE LUMEN TUBE (37 FR SHILEY ET TUBE), THE BRONCHOSCOPE BECAME CRIMPED ON ITSELF AND THEN BECAME STUCK IN THE TUBE. WHEN THE BRONCHOSCOPE WAS PULLED OUT, THE OUTER SHEATH WAS OVER THE CAMERA WHICH LED THE MD TO TAKE X-RAYS AND PERFORM ANOTHER BRONCHOSCOPY TO CONFIRM THAT NO PIECES OF THE BRONCHOSCOPE WERE LEFT INSIDE THE PATIENT. THE CUSTOMER CONFIRMED THAT NO PIECES DETACHED OR FELL INSIDE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY AND THEY REPORTED THE PATIENT WAS FINE.

  Patient problems: Unintended Extubation

  MAUDE report 15709677 ↗
• MalfunctionFeb 22, 2022Display or Visual Feedback Problem; Optical Problem; Display or Visual Feedback Problem; Optical Problem

  THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THE LIGHT ON THE BRONCHOSCOPE WENT OUT. THE CUSTOMER ATTEMPTED TO UNPLUG AND RE-PLUG THE BRONCHOSCOPE, BUT THE LIGHT WOULD NOT TURN BACK ON. THE CUSTOMER COMPLETED THE PROCEDURE USING A DIFFERENT MANUFACTURER DEVICE. NO HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581330 ↗
• MalfunctionJun 29, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 BRONCHOSCOPE, THEY WERE UNABLE TO ARTICULATE THE DISTAL TIP OF THE SCOPE DUE TO A KINK IN THE BRONCHOSCOPE. THE CUSTOMER STATED THAT THE DAMAGE WAS LOCATED WHERE THE TUBE AND TUBE RETAINER MEET ON THE BRONCHOSCOPE. AN UNSPECIFIED DELAY IN THE PROCEDURE OCCURRED AS A BACKUP BFLEX 3.8 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089053 ↗
• MalfunctionMar 9, 2021Break; Physical Resistance/Sticking

  THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 BRONCHOSCOPE, THE TIP OF THE BRONCHOSCOPE GOT STUCK AT THE BIFURCATION OF THE BRONCHIAL AND TRACHEAL LUMENS AND THE DISTAL END OF THE SCOPE BROKE OFF. THE TIP REMAINED IN THE COVIDEN 37 FR ENDOBRONCHIAL TUBE BUT WAS STILL ATTACHED TO THE BRONCHOSCOPE BY THE SCOPE'S INTERNAL WIRING. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446627 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING AN EMERGENCY PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, THE SLEEVE THAT IS OVER THE TIP, DETACHED FROM THE BFLEX. A DELAY IN THE PROCEDURE OF LESS THAN A MINUTE OCCURRED AS ANOTHER GLIDESCOPE BFLEX 3.8 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT, OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901168 ↗
• MalfunctionJul 15, 2020Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE, UPON EXTRACTION OF THE BRONCHOSCOPE, THE ANESTHESIOLOGIST ENCOUNTERED RESISTANCE REMOVING THE INSERTION TUBE. UPON REMOVAL, THE DISTAL TIP DETACHED INSIDE THE DOUBLE-LUMEN TUBE (DLT) AT THE BIFURCATION OF THE BRONCHIAL AND TRACHEA LUMENS. THE PATIENT REQUIRED EXTUBATION AND RE-INTUBATION AS A RESULT. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280553 ↗