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GlideScope® BFlex™ 5.8Recalls & reported problems

Verathon Medical (Canada) ULC · Class 2

Quick summary

This Verathon GlideScope BFlex single-use bronchoscope is a thin, flexible scope used to look down patients' airways. The 29 reports mostly describe the scope's tip breaking off or coming apart during a procedure, sometimes leaving a piece inside the patient's airway or breathing tube, and also frozen or blank video images on the monitor. No deaths or injuries were reported. 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
29
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00879123006400), received between Nov 17, 2020 and Sep 12, 2023 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Display or Visual Feedback Problem11
  • No Display/Image6
  • Detachment of Device or Device Component5
  • Break4
  • Physical Resistance/Sticking2
  • Use of Device Problem2
  • Device Dislodged or Dislocated1
  • Entrapment of Device1

Patient problems

  • No Clinical Signs, Symptoms or Conditions28
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 12, 2023Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

    A USER FACILITY REPORTED VIA MEDWATCH REPORT NUMBER (B)(4). THAT DURING A BRONCHOSCOPY DONE AT THE BEDSIDE BY AN INTESIVIST IN THE INTENSIVE CARE UNIT (ICU), THE TIP OF THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE BEING USED BROKE OFF INSIDE THE PATIENT. UPON FOLLOWING UP WITH THE FACILITY REGARDING THE REPORTED EVENT, THE FACILITY REPORTED THAT THE TIP BROKE WHEN BEING RETRACTED FROM THE ET TUBE. IT WAS REPORTED THAT THE USER EXPERIENCED DIFFICULTY PASSING THE BRONCHOSCOPE THROUGH THE ET TUBE DUE TO A BRONCHIAL BLOCK IN PLACE. THE MANUFACTURER AND MODEL OF THE ET TUBE WAS NOT PROVIDED. THE DETACHED TIP WAS SUCCESSFULLY REMOVED BY A PULMONOLOGIST. NO FURTHER MEDICAL TREATMENT OR HOSPITALIZATION WAS REQUIRED FOR THE PATIENT DUE TO THE REPORTED BRONCHOSCOPE TIP SEPARATION; HOWEVER, DUE TO THE PATIENT ALREADY BEING IN A CRITICAL CONDITION, THEY WERE ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17730350 ↗
  • MalfunctionAug 15, 2023

    THE TIP OF A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE BROCH OFF DURING A BRONCHOSCOPY DONE AT BEDSIDE BY INTENSIVIST IN INTENSIVE CARE UNIT (ICU). PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17548482 ↗
  • MalfunctionJul 18, 2023Break; Break

    A CUSTOMER REPORTED THAT DURING A TRACHEOSTOMY WITH BRONCHOSCOPY PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, A PIECE OF THE BRONCHOSCOPE CAMERA/TIP BROKE OFF INTO THE PATIENT'S RIGHT BRONCHUS. THE BRONCHOSCOPE TIP BROKE WHEN BEING RETRACTED AFTER MULTIPLE ATTEMPTS FROM A SIZE 8.0 MM COVIDIEN SHILEY HI-LO ORAL/NASAL TRACHEAL TUBE. THE PHYSICIAN NOTED THAT THERE WAS A "KINK" WITH THE ETT AT THE BEGINNING OF THE CASE. IT WAS REPORTED THAT MEDLINE LUBRICATING JELLY WAS USED WITH THE BRONCHOSCOPE AND LIBERALLY APPLIED CONSISTENT WITH OTHER BRONCHOSCOPY PROCEDURES. THE BRONCHOSCOPE TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WHICH INCREASED THE PROCEDURE TIME BY 20-30 MINUTES. NO HARM TO THE PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17343380 ↗
  • MalfunctionJul 18, 2023Erratic or Intermittent Display; Display or Visual Feedback Problem; Erratic or Intermittent Display; Display or Visual Feedback Problem

    A CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, THE IMAGE WAS FREEZING ON THE SCREEN. THE PROCEDURE WAS COMPLETED USING A BACKUP BFLEX BRONCHOSCOPE WHICH WAS MADE AVAILABLE IMMEDIATELY. THE CUSTOMER ALSO REPORTED PHYSICAL DAMAGE TO THE BRONCHOSCOPE SYSTEM'S CABLE CONNECTOR, HOWEVER, NO FREEZING IMAGE OCCURRED WHEN THEY CONNECTED THE BACKUP BFLEX BRONCHOSCOPE TO THE SAME CABLE. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17343378 ↗
  • MalfunctionFeb 21, 2023Break; Use of Device Problem; Break; Use of Device Problem

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE TO REMOVE A LARGE GRANULOMA CAUSING AN AIRWAY OBSTRUCTION ON A VERY CRITICAL 65-YEAR-OLD FEMALE PATIENT, THE PHYSICIAN FIRST ATTEMPTED TO REMOVE THE AIRWAY OBSTRUCTION BY UTILIZING A GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE INSERTED INTO A 6.0 SIZE SHILEY TRACHEOSTOMY TUBE. THE PHYSICIAN REPORTED NOT BEING ABLE TO REMOVE THE OBSTRUCTION USING THE GLIDESCOPE BFLEX 3.8 SINGLE-USE BRONCHOSCOPE AND SWITCHED TO THE LARGER SIZE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE IN ANOTHER ATTEMPT TO REMOVE THE AIRWAY OBSTRUCTION. THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE WAS USED, BUT AGAIN THE PROCEDURE WAS REPORTED AS UNSUCCESSFUL IN REMOVING THE AIRWAY OBSTRUCTION. AN ENT DOCTOR WAS CALLED IN FOR CONSULTATION, AND IT WAS DETERMINED THAT THE PATIENT WAS TO BE SENT TO SURGERY. IT WAS REPORTED THAT NO OPERATING ROOMS WERE AVAILABLE AT THAT TIME. AT SOME POINT PRIOR TO SURGERY THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE WAS REMOVED FROM THE 6.0 SIZE SHILEY TRACHEOSTOMY TUBE, AND THE TIP WAS REPORTED TO HAVE "SHEARED OFF" AND FELL INSIDE THE PATIENT. THE PATIENT WAS REPORTED TO HAVE PASSED PRIOR TO GOING INTO SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16410239 ↗
  • MalfunctionNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, THE TIP BROKE OFF AND REMAINED LODGED INSIDE THE PATIENT'S ENDOTRACHEAL TUBE (ETT). AN EMERGENT REINTUBATION OF THE PATIENT WAS PERFORMED. NO HARM TO THE PATIENT WAS REPORTED. UPON FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS REPORTED THAT THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE WAS LUBRICATED WITH MEDLINE LUBRICATION JELLY AND WAS INSERTED INTO A COVIDIEN SHILEY HI-LO ORAL/NASAL TRACHEAL TUBE CUFFED SIZE 8.0 MM. THE CUSTOMER REPORTED THE BRONCHOSCOPE HAD BEEN INSERTED AND RETRACTED AT LEAST TWICE INSIDE THE ETT. THE INITIAL RETRACTION WAS DUE TO THE SUCTION BECOMING CLOGGED. THE CUSTOMER WAS ABLE TO CLEAR THE SUCTION AND REINSERTED THE BRONCHOSCOPE INTO THE ETT. DURING THE SECOND RETRACTION OF THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE FROM THE ETT THE TIP HAD SEPARATED NEAR THE BASE OF THE ETT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15709792 ↗
  • MalfunctionOct 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE FOLLOWING ISSUE WAS REPORTED VIA MANUFACTURER AND USER FACILITY REPORT NUMBER "MW5111733" WHICH STATED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, "MD WAS PERFORMING A BRONCHOSCOPY ON A PATIENT AND THE TIP OF THE GLIDESCOPE BFLEX BROKE OFF AND HAD TO BE RETRIEVED BY THE MD WITH FORCEPS. ABNORMAL CHEST X-RAY. EVENT ABATED AFTER USE STOPPED." VERATHON CONTACTED THE CUSTOMER FOR MANUFACTURER AND USER FACILITY REPORT NUMBER "MW5111733" AND THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE REPORTED EVENT. IT WAS REPORTED BY THE CUSTOMER THAT WHEN PASSING THE BRONCHOSCOPE LUBRICATED WITH A WATER-SOLUBLE JELLY, THE END-USER FELT "SIGNIFICANT RESISTANCE" WHEN INSERTING THE BRONCHOSCOPE INTO A 7.0 CUFFED ENDOTRACHEAL TUBE. THEY REPORTED THAT THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE DETACHMENT OCCURRED DURING THE RETRACTION OF THE BRONCHOSCOPE FROM THE ENDOTRACHEAL TUBE. THE MEDICAL PROFESSIONALS AT THE CUSTOMER'S FACILITY HAD CONFIRMED THE FOLLOWING DEVICE DETACHMENT DID NOT CAUSE OR CONTRIBUTE TO ANY PATIENT HARM, INJURY OR DEATH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15580479 ↗
  • MalfunctionAug 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    THE FOLLOWING WAS REPORTED VIA MANUFACTURER AND USER FACILITY REPORT NUMBER 2900390000-2022-8007 WHICH STATED THAT DURING A BRONCHOSCOPY, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, AFTER REMOVING THE BRONCHOSCOPE, THE TIP OF THE BRONCHOSCOPE WAS DANGLING WITH A FINE WIRE/THREAD. ANOTHER FIBEROPTIC BRONCHOSCOPE WAS USED TO VISUALIZE THE LUNG FIELDS FOR ANY LEFTOVER PIECES. NO DELAY IN THE PROCEDURE OR HARM TO THE PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15233900 ↗
  • MalfunctionMay 31, 2022No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, THE IMAGE FROZE SEVERAL TIMES AND THEN THE IMAGE DISAPPEARED DISPLAYING A BLACK SCREEN. THE CUSTOMER REPORTED UNPLUGGING/RE-PLUGGING THE GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE UP TO THREE (3) TIMES UNSUCCESSFULLY IN ORDER TO GET THE IMAGE TO REAPPEAR ON THE CONNECTED VIDEO MONITOR. THE PROCEDURE WAS COMPLETED USING A NEW GLIDESCOPE BFLEX SINGLE-USE BRONCHOSCOPE, WHICH WAS MADE AVAILABLE IN AN UNSPECIFIED AMOUNT OF TIME. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14548464 ↗
  • MalfunctionMar 8, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, THE IMAGE FROZE. 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 13694665 ↗
  • MalfunctionFeb 1, 2022Use of Device Problem; Use of Device Problem; Detachment of Device or Device Component; Physical Resistance/Sticking

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, THE BRONCHOSCOPE GOT CAUGHT INSIDE THE PATIENT'S TRACH TUBE WHICH ENDED UP PULLING THE INNER CANNULA OUT. THE BRONCHOSCOPE, INNER CANNULA, AND THE TRACH TUBE HAD TO BE TAKEN OUT ALL-TOGETHER TO REMOVE THE BRONCHOSCOPE FROM THE PATIENT'S AIRWAY. UPON REMOVAL THE PATIENT TRACH TUBE WAS EVENTUALLY CHANGED OUT. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13416370 ↗
  • MalfunctionJan 25, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE, THE LIGHT SOURCE "FAILED". THE PROCEDURE WAS COMPLETED USING ANOTHER BRONCHOSCOPE, WHICH WAS MADE AVAILABLE IN A UNSPECIFIED AMOUNT OF TIME. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13343059 ↗
  • MalfunctionOct 26, 2021Break; Break

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, WHEN ATTEMPTING TO WITHDRAW THE BRONCHOSCOPE FROM A 7.5MM ET TUBE, THE CUSTOMER FELT RESISTANCE. THE CUSTOMER PULLED HARDER CAUSING THE TIP OF THE BRONCHOSCOPE TO GET STUCK AND BREAK OFF INSIDE THE ET TUBE. THE ET TUBE WAS REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12698978 ↗
  • MalfunctionOct 19, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE FROZE WHILE THE BRONCHOSCOPE WAS INSERTED IN THE PATIENT'S ET TUBE. 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 12658559 ↗
  • MalfunctionOct 12, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE WOULD FREEZE. A DELAY IN THE PROCEDURE OF AN UNDISCLOSED DURATION OCCURRED AS A BACK-UP GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12616657 ↗
  • MalfunctionSep 21, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE BRONCHOSCOPE WAS PRODUCING A BAD IMAGE; THE RESOLUTION WAS BAD AND THEY COULDN'T SEE ANYTHING. A NEGLIGIBLE DELAY IN THE PROCEDURE OCCURRED AS A BACKUP BFLEX 5.0 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12510860 ↗
  • MalfunctionSep 2, 2021Image Display Error/Artifact

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE SCREEN WOULD GO GREEN AND RED. THERE WAS ALSO A CLOUD OVER THE SCREEN WHEN THERE WASN'T A RED AND GREEN IMAGE. A DELAY IN THE PROCEDURE OF AN UNDISCLOSED DURATION OCCURRED AS A BACKUP BFLEX 5.8 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12418762 ↗
  • MalfunctionJul 6, 2021Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE WAS DARK AND PIXELATED WHILE THE BRONCHOSCOPE WAS IN THE PATIENT'S MOUTH. THE CUSTOMER REMOVED THE BRONCHOSCOPE AND SWAPPED IT WITH A NEW ONE AND WAS ABLE TO COMPLETE THE CASE. A DELAY IN THE PROCEDURE OF AN UNDISCLOSED DURATION OCCURRED AS ANOTHER BFLEX BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12122768 ↗
  • MalfunctionJul 6, 2021No Display/Image

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE WAS VERY DARK. THE CUSTOMER SWAPPED OUT THE BRONCHOSCOPE AND IT RESOLVED THE ISSUE. 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 12122747 ↗
  • MalfunctionJun 15, 2021No Display/Image; No Display/Image

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE ON THE SCREEN BLACKED OUT. 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 12002863 ↗
  • MalfunctionJun 15, 2021No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY CARE PROCEDURE, USING A GLIDESCOPE CORE 15-INCH MONITOR WITH A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE ON THE SCREEN BLACKED OUT. 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 12002853 ↗
  • MalfunctionJun 8, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE IMAGE WAS, "VERY HARD TO SEE" DUE TO A RED SCREEN. THE PROCEDURE WAS COMPLETED USING A REUSABLE SCOPE, WHICH WAS MADE AVAILABLE IN AN UNDIVULGED AMOUNT OF TIME. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11960465 ↗
  • MalfunctionMay 25, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE SCREEN FROZE WHEN THE BRONCHOSCOPE WAS BEING INSERTED INTO THE ENDOTRACHEAL TUBE. THE CUSTOMER WAS ABLE TO RESET THE SCREEN BY UNPLUGGING AND RE-PLUGGING THE GLIDESCOPE QUICKCONNECT CABLE. WITHIN A FEW SECONDS, AS THEY CONTINUED TO INSERT THE BFLEX BRONCHOSCOPE INTO THE ENDOTRACHEAL TUBE, THE SCREEN FROZE AGAIN. A DELAY OF AN UNSPECIFIED DURATION OCCURRED AS A BACKUP GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE WAS OBTAINED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11882006 ↗
  • MalfunctionApr 7, 2021Entrapment of Device; Device Dislodged or Dislocated

    THIS ISSUE WAS REPORTED VIA MANUFACTURER AND USER FACILITY REPORT NUMBER MW5099179 WHICH STATED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE SCOPE'S OUTER SHEATH BECAME DETACHED. WHEN THE CUSTOMER ATTEMPTED TO REMOVE THE SCOPE, THE SHEATH REMAINED LODGED IN THE ENDOTRACHEAL TUBE. THE ENDOTRACHEAL TUBE HAD TO BE REMOVED AND PATIENT RE-INTUBATED. NO HARM TO THE PATIENT OR USER WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 11631620 ↗
  • MalfunctionApr 6, 2021Failure to Align; Failure to Align

    THE CUSTOMER REPORTED THAT DURING A PATIENT PROCEDURE, USING A GLIDESCOPE BFLEX 5.8 BRONCHOSCOPE, THE BRONCHOSCOPE TIP WOULD FLEXED UP AND TO THE RIGHT BUT NOT STRAIGHT UP AND DOWN. THE CUSTOMER NOTED THAT THE BRONCHOSCOPE TIP WAS NOT MOVING CORRECTLY WHEN CONTROLLED BY THE HANDLE. INSTEAD OF MOVING UPWARD AND STAYING CENTERED, IT WOULD MOVE UP AND TO THE RIGHT. 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 11624280 ↗

Other Bronchoscope (Flexible Or Rigid) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.