GlideScope® BFlex™ 5.0Recalls & reported problems
Verathon Medical (Canada) ULC · Class 2
All models of GlideScope (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This GlideScope BFlex 5.0, a single-use bronchoscope made by Verathon, has 23 adverse event reports naming its identifier, with no deaths and 1 injury. The reports mostly describe parts of the scope's tip breaking off or detaching during procedures — sometimes leaving fragments in the patient's airway that had to be retrieved — and the camera image cutting out or turning black. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00879123006332), received between Dec 23, 2019 and May 30, 2023 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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
Device problems
- Detachment of Device or Device Component7
- No Display/Image6
- Device-Device Incompatibility3
- Display or Visual Feedback Problem3
- Off-Label Use3
- Device Damaged by Another Device2
- Material Fragmentation2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information3
- No Consequences Or Impact To Patient3
- Airway Obstruction1
- Foreign Body In Patient1
- Low Oxygen Saturation1
- No Known Impact Or Consequence To Patient1
- Unintended Extubation1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2023Display or Visual Feedback Problem; Poor Quality Image; Display or Visual Feedback Problem; Poor Quality Image
A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE IMAGE WOULD INTERMITTENTLY GO BAD AND THEY COULDN'T SEE ANYTHING. THE PROCEDURE WAS COMPLETED USING A BACKUP GLIDESCOPE BFLEX 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. FOLLOWING THE REPORTED EVENT, THE CUSTOMER'S VERATHON TERRITORY MANAGER WAS ONSITE AND ASSISTED WITH TROUBLESHOOTING BUT WAS UNABLE TO CONFIRM IF THE ISSUE WAS ISOLATED TO THE GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE OR THE CONNECTED GLIDESCOPE QUICKCONNECT CABLE USED WITH THE BRONCHOSCOPE DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020388 ↗InjuryMar 8, 2023Difficult to Remove; Material Separation; Detachment of Device or Device Component; Difficult to Remove; Material Separation; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE BRONCHOSCOPE BECAME LODGED IN THE ET TUBE UPON REMOVAL. IT WAS REPORTED THAT THE DOCTOR PULLED THE SCOPE TO TRY AND DISLODGE IT, BUT ONCE IT WAS REMOVED THEY NOTICED THAT THE METAL END PIECE WAS OFF AND THE END OF THE BRONCHOSCOPE WAS STRETCHED AND TORN. A X-RAY WAS TAKEN AT THE BEDSIDE AND THE OBJECT WAS SHOWN IN THE PATIENT'S LEFT MAINSTEM BRONCHUS. A CT SCAN WAS PLANNED TO BETTER ASCERTAIN THE LOCATION AND THE PATIENT WAS BROUGHT TO THE OR FOR RETRIEVAL OF THE METAL PIECE. TO DATE, NO FURTHER INFORMATION WAS MADE AVAILABLE REGARDING THE STATUS OF THE PATIENT'S CONDITION.
Patient problems: Foreign Body In Patient
MAUDE report 16507524 ↗MalfunctionJan 17, 2023Flaked; Flaked
A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE PHYSICIAN NOTICED WHITE FLAKES IN THE PATIENT'S AIRWAY. UPON REMOVING THE BRONCHOSCOPE, THEY NOTICED THE COATING AT THE TIP OF THE BRONCHOSCOPE WAS PEELING AWAY. THEY REPORTED USING A REUSABLE SCOPE AND FORCEPS TO REMOVE ALL THE WHITE PIECES FROM THE PATIENT'S AIRWAY. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16185275 ↗MalfunctionNov 8, 2022Off-Label Use; Detachment of Device or Device Component; Device Damaged by Another Device; Device-Device Incompatibility; Off-Label Use; Detachment of Device or Device Component; Device Damaged by Another Device; Device-Device Incompatibility
A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, WHEN PULLING THE BRONCHOSCOPE OUT OF THE DOUBLE LUMEN TUBE (41 FR SHILEY), THE CAMERA TIP HAD DETACHED AND THE DISTAL TIP OF THE BRONCHOSCOPE WAS FRAYED. THE PHYSICIAN CLAMPED THE TRACHEAL SIDE OF THE DOUBLE LUMEN TUBE TO ENSURE THE FORCED POSITIVE AIR DIDN'T PUSH ANYTHING INTO THE PATIENT'S RIGHT LUNG. THEY WORKED TO SAFELY OXYGENATE THE PATIENT THROUGH THE BRONCHIAL SIDE OF THE TUBE. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH A 39 FR DLT AND A DIFFERENT MANUFACTURER SCOPE. THE PHYSICIAN PERFORMED A DIAGNOSTIC VIEW OF THE RIGHT LUNG BRONCHI WITH NO REPORTED INJURY OR FOREIGN BODY. A FORCEPS WAS USED TO REMOVE THE LODGED CAMERA FROM THE DISTAL TIP OF THE 41 FR DLT. X-RAYS WERE TAKEN AND CONFIRMED NO FOREIGN BODIES OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 15753241 ↗MalfunctionNov 1, 2022Off-Label Use; Retraction Problem; Device Damaged by Another Device; Device-Device Incompatibility; Off-Label Use; Retraction Problem; Device Damaged by Another Device; Device-Device Incompatibility
A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE SCOPE GOT STUCK UPON REMOVAL AND BROKE APART INSIDE THE ET TUBE (39 FR DOUBLE-LUMEN TUBE). ALL COMPONENTS OF THE SCOPE WERE RETAINED WITHIN THE ET TUBE AND THE TUBE WAS REMOVED. X-RAYS WERE TAKEN POST-OPERATIVELY AS WELL AS VISUAL INSPECTION OF THE ENTIRE AREA ENTERED WITH NO FOREIGN BODIES RETAINED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15709726 ↗MalfunctionSep 13, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE IMAGE TURNED "BLACK" WITH "FUZZY" LINES APPEARING ON THE CONNECTED GLIDESCOPE CORE MONITOR SCREEN. THE CUSTOMER ATTEMPTED TO RE-BOOT THE GLIDESCOPE CORE MONITOR SEVERAL TIMES, BUT IT DID NOT RESOLVE THE REPORTED IMAGE TURNING "BLACK" WITH "FUZZY" LINES. THE PROCEDURE WAS COMPLETED USING ANOTHER VERATHON GLIDESCOPE CORE SYSTEM AND A NEW GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, WHICH WAS MADE AVAILABLE IN AN UNSPECIFIED AMOUNT OF TIME. AFTER THE PROCEDURE, BASED ON TROUBLESHOOTING THE CUSTOMER PERFORMED, THE CUSTOMER REPORTED THE ISSUE MAY HAVE BEEN ISOLATED TO JUST THE GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE INITIALLY USED. THERE WAS NO REPORT OF ANY HARM TO THE PATIENT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15411200 ↗MalfunctionJun 28, 2022Off-Label Use; Detachment of Device or Device Component; Device-Device Incompatibility; Off-Label Use; Detachment of Device or Device Component; Device-Device Incompatibility
A CUSTOMER REPORTED VIA MEDWATCH FORM FDA 3500A THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE DISTAL COMPONENTS OF THE SCOPE HAD BROKEN OFF INTO THE TRACHEAL LUMEN OF THE DOUBLE-LUMEN TUBE. THE TIP OF THE EXTERIOR SHELL OF THE SCOPE HAD SEPARATED FROM THE INTERIOR COMPONENTS. ONE LUNG VENTILATION WAS INITIATED WITHOUT ISSUE TO PREVENT PASSAGE OF THE COMPONENTS FURTHER DOWN THE TRACHEAL LUMEN. THE OBJECT WAS REMOVED FROM THE TRACHEAL LUMEN WITH ASSISTANCE FROM INTERVENTIONAL PULMONOLOGY. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14844673 ↗MalfunctionMar 1, 2022Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WITH A DOUBLE-LUMEN TUBE, A PIECE OF PLASTIC FROM THE BRONCHOSCOPE BROKE OFF AND RETAINED IN THE PATIENT'S AIRWAY. A THERAPEUTIC BRONCHOSCOPY WAS PERFORMED IN COMBINATION WITH THE USE OF BRONCHOSCOPE ALLIGATOR FORCEPS / GRASPERS TO REMOVE THE BROKEN BRONCHOSCOPE PIECE SUCCESSFULLY. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13636467 ↗MalfunctionJan 11, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WITH A SIZE 8.0 MM ENDOTRACHEAL TUBE, WHEN REMOVING THE BRONCHOSCOPE FROM THE ENDOTRACHEAL TUBE THE TIP OF THE BRONCHOSCOPE SEPARATED AND WENT MISSING. ALL THE CUSTOMER SAW AT THE END WAS A "YELLOW STRING". THE CUSTOMER IMMEDIATELY CHECKED THE AIRWAY OF THE PATIENT WITH A NEW BRONCHOSCOPE, BUT WAS UNABLE TO SEE ANYTHING INSIDE THE AIRWAY. A FOLLOW-UP CHEST X-RAY WAS PERFORMED ON THE PATIENT, BUT DID NOT REVEAL ANY FOREIGN BODY IN THE PATIENT'S LUNGS. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13231123 ↗MalfunctionOct 5, 2021Poor Quality Image
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, THE IMAGE PRODUCED WAS BLACK AND DARK RED. 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 12577774 ↗MalfunctionAug 10, 2021Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, PIECES OF THE BRONCHOSCOPE'S SHEATHING CAME OFF AND FELL INTO THE PATIENT'S LUNG. THE CUSTOMER STATED THAT SOME OF THE PIECES COULD NOT BE RECOVERED. A DELAY IN THE PROCEDURE OF LESS THAN THREE (3) MINUTES OCCURRED AS A BACKUP BFLEX WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12302539 ↗MalfunctionMay 6, 2021Display or Visual Feedback Problem; Image Display Error/Artifact; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT DURING A BEDSIDE PERCUTANEOUS TRACHEOTOMY, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, THE PICTURE KEPT FREEZING. THE SCOPE WAS REMOVED AND AN UNIDENTIFIED REUSABLE SCOPE / TOWER WAS BROUGHT IN TO FINISH THE PROCEDURE. NO INDICATION ON HOW MUCH TIME ELAPSED TO GET THE BACK-UP DEVICE INTO OPERATION. NO HARM TO THE PATIENT OR USER WAS REPORTED. IT SHOULD BE NOTED THAT THE GLIDESCOPE BFLEX SINGLE USE BRONCHOSCOPE'S OPERATIONS AND MAINTENANCE MANUAL (OMM) STATES THAT THE BFLEX 5.0 BRONCHOSCOPE CAN BE INSERTED USING ANY STANDARD ORAL OR NASAL INSERTION TECHNIQUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11784653 ↗MalfunctionApr 20, 2021No Display/Image
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, THE IMAGE WENT BLANK. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11695494 ↗MalfunctionApr 7, 2021No Display/Image; No Display/Image
THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, THE IMAGE WOULD GO DARK. THE CUSTOMER'S BIOMED TESTED THE BRONCHOSCOPE AND NOTED THAT THE IMAGE WAS TOO POOR (DARK / BLACK) TO SAFELY MANEUVER AN AIRWAY. 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 11631622 ↗MalfunctionApr 6, 2021No Display/Image; Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, THE IMAGE WOULD GO DARK. A DELAY IN THE PROCEDURE OF AN UNKNOWN DURATION OCCURRED AS AN UNDISCLOSED DEVICE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11624254 ↗MalfunctionApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2021, VERATHON RECEIVED INFORMATION FROM OUR DISTRIBUTOR, CANADIAN HEALTH SPECIALTIES, LTD. ("CHS"), THAT DURING A PATIENT PROCEDURE THE TIP OF A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE ("BRONCHOSCOPE") BECAME DETACHED AND REMAINED IN THE ENDOTRACHEAL (ET) TUBE. THE DISTRIBUTOR REPORTED THAT DURING AN AWAKE INTUBATION THE BRONCHOSCOPE WAS INSPECTED, PREPARED, AND LOADED INTO A 7.0 MM COVIDEN SHILEY ET TUBE. REPORTEDLY THE ADVANCEMENT AND PLACEMENT OF THE ET TUBE WAS UNREMARKABLE, WITH NO RESISTANCE NOTED. UPON SUCCESSFUL PLACEMENT OF THE ET TUBE THE BRONCHOSCOPE WAS BEING WITHDRAWN WHEN SLIGHT RESISTANCE WAS FELT. UPON REMOVAL OF THE BRONCHOSCOPE FROM THE ET TUBE THE ANESTHESIOLOGIST NOTICED THAT THE TIP OF THE BRONCHOSCOPE WAS MISSING, AND THE WIRES WERE EXPOSED. THE PATIENT WAS PLACED ON A VENTILATOR. A SECOND BRONCHOSCOPE WAS USED TO INSPECT THE ET TUBE. THE TIP OF THE FIRST BRONCHOSCOPE WAS OBSERVED INSIDE THE ET TUBE. A CHEST X-RAY CONFIRMED THAT TWO PIECES REMAINED IN THE PATIENT. THE THORACIC TEAM USED FORCEPS, PASSED THROUGH A THIRD BRONCHOSCOPE, TO RECOVER THE PIECES NOTED ON THE CHEST X-RAY. THE THORACIC TEAM THEN EXPLORED THE AIRWAY TO CONFIRM NO OTHER REM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11609155 ↗MalfunctionFeb 9, 2021Material Fragmentation; Material Fragmentation; Detachment of Device or Device Component; Device Fell
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, A PIECE OF THE SCOPE'S SHEATHING CAME OFF AND FELL INTO THE PATIENT'S LUNG. THE CUSTOMER STATED THAT THEY BELIEVE THEY WERE ABLE TO SUCTION THE PIECE OUT. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11304127 ↗MalfunctionJan 13, 2021Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE, THE BRONCHOSCOPE WAS PRODUCING AN INTERMITTENT CAMERA IMAGE. A DELAY IN THE PROCEDURE OF AN UNKNOWN DURATION OCCURRED AS A BACK-UP BFLEX WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11159142 ↗MalfunctionAug 18, 2020No Display/Image; Output Problem; No Display/Image
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE DEVICE WOULD NOT GENERATE AN IMAGE. IT WAS REPORTED THAT OTHER BRONCHOSCOPES IN THE SAME BOX WERE WORKING FINE. AN UNSPECIFIED DELAY IN THE PROCEDURE OCCURRED AS ANOTHER GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10420106 ↗MalfunctionJul 24, 2020Therapeutic or Diagnostic Output Failure
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE IMAGE ON THE GLIDESCOPE CORE 10 INCH MONITOR SCREEN WAS INTERMITTENTLY FREEZING. ANOTHER GLIDESCOPE CORE 10 AND GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WAS BROUGHT FROM THE OTHER ICU AND THE INTERMITTENT FREEZING ISSUE RECURRED. 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 10323052 ↗MalfunctionJul 15, 2020Material Separation; Material Separation
THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE, THE DISTAL TIP (CAMERA/LIGHT MODULE) DETACHED AND REMAINED LODGED IN THE PATIENT'S DISTAL TRACHEA JUST ABOVE THE CARINA. THE ANESTHESIOLOGIST WAS ABLE TO ADVANCE THE SCOPE INTO THE TRACHEA, HOWEVER AFTER THE INSPECTION WAS COMPLETE, HE ENCOUNTERED RESISTANCE ON THE INSERTION TUBE DURING EXTRACTION OF THE BRONCHOSCOPE. AS THE PATIENT BEGAN TO DESATURATE, THE ANESTHESIOLOGIST APPLIED FURTHER FORCE AT WHICH POINT THE DISTAL TIP DETACHED COMPLETELY. THE TIP WAS REMOVED UTILIZING ENDOSCOPIC FORCEPS WITH A FIBEROPTIC SCOPE. NO DELAY IN THE PROCEDURE, USE OF A BACKUP DEVICE, OR HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: Airway Obstruction; Low Oxygen Saturation
MAUDE report 10280556 ↗MalfunctionJul 15, 2020Loose or Intermittent Connection; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THAT DUE TO A DIFFICULT INTUBATION THEY ELECTED TO SWITCH TO BRONCHIAL ASSIST DURING THE PATIENT PROCEDURE USING A GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE. DURING THE INTUBATION WITH BRONCHIAL ASSIST, THE IMAGE ON THE MONITOR SCREEN FROZE. THE ANESTHESIA TECHNICIAN UNPLUGGED THE BRONCHOSCOPE, CUT THE POWER TO THE SYSTEM, POWERED THE SYSTEM BACK ON AND PLUGGED THE BRONCHOSCOPE BACK IN. THE ERROR ICON FOR NO ATTACHED SCOPE DETECTED OCCURRED AND THE BRONCHOSCOPE WOULD NOT RESUME FUNCTIONING. THE ANESTHESIA TECHNICIAN OBTAINED ANOTHER GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WHICH WORKED LIKE IT WAS SUPPOSED TO WITH ZERO PROBLEMS. AFTER THE PROCEDURE, THE ANESTHESIA TECHNICIAN NOTED THAT THE INITIAL GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE APPEARED TO HAVE A LOOSE CONNECTION. AN UNKNOWN DELAY IN THE PROCEDURE OCCURRED AS A SECOND GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10280555 ↗MalfunctionDec 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE SHAFT OF THEIR GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPE HAD SEPARATED IN THE 7.0 ET TUBE DURING A PATIENT PROCEDURE. THERE WAS NO EVIDENCE THAT MATERIAL WAS LEFT BEHIND IN THE PATIENT. NO HARM TO THE PATIENT OR USER WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9512203 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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