MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number 0570-0374

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

The customer reported that during an emergency care patient procedure, using a glidescope bflex 5.0 single-use bronchoscope with a size 6.0 mm endotracheal tube, the bronchoscope became stuck inside the endotracheal tube when attempting to remove it.When the bronchoscope was eventually removed from the endotracheal tube the end of the bronchoscope was frayed.Two pieces, the "metal ring" and "plastic end with the light" had separated from the end of the bronchoscope.The customer was able to find the "metal ring" lodged inside the endotracheal tube, while the "plastic end" was found upon performing an x-ray on the patient's lungs.The patient was transferred to an intensive care unit unrelated to this incident and upon last contact with the customer the patient was doing well.

Manufacturer Narrative

The reported glidescope bflex 5.0 bronchoscope was returned to verathon along with the shiley evac endotracheal tube with taperguard cuff (6.0 mm) that was used in the procedure.A verathon sustaining engineer evaluated the returned bronchoscope and endotracheal tube and confirmed that the camera assembly was missing from the distal tip end of the bronchoscope, and the metal coupler of the bronchoscope was lodged inside the customer's returned endotracheal tube.The verathon sustaining engineer began their investigation by first examining the returned shiley evac endotracheal tube with taperguard cuff (6.0 mm).The endotracheal tube was cut open where the reported bronchoscope metal coupler was lodged, and the verathon engineer examined the cross section of the tube.It was observed that the endotracheal tube had a dorsal suction lumen with a "non-circular" cross section measuring at an inner diameter (id) of 5.0 mm.This section's measurement was smaller than the rest of the endotracheal tube which was measured at 6.0 mm.The returned bronchoscope distal tip end was also examined.Evidence was found showing that the tip sheath had most likely peeled back when being withdrawn from the endotracheal tube but had no signs of tearing; damage would be expected to the sheath if adhesive was applied during manufacturing.The sheath tip was inspected for adhesive residue, but the verathon sustaining engineer was unable to confirm any traces found.The camera assembly housing of the bronchoscope where adhesive is directly applied and would have provided a better analysis of how much adhesive was applied during manufacturing was not returned to verathon.From what was analyzed, the verathon sustaining engineer attempted to recreate the following reported event.They prepared three (3) test glidescope bflex 5.0 bronchoscope samples that were specifically manufactured with insufficient to no glue adhesive applied to the camera housing and sheath tip of the bronchoscopes.The bronchoscopes were tested with shiley evac endotracheal tubes with taperguard cuff (6.0 mm) samples without the use of lubrication.On follow-up communication with the customer, it was determined that no lubrication was being utilized during the reported procedure.Upon testing and withdrawal of the three (3) test bronchoscopes from the test endotracheal tubes it was found that two (2) resulted in complete roll back of the tip sheath.The remaining test sample bronchoscope passed through the endotracheal tube without any damage occurring.In all test samples there was increased resistance at the dorsal lumen section of the test endotracheal tubes when attempting to withdraw the test bronchoscopes.They also confirmed in all test instances there were no complete detachment of the camera housing.Based off the evidence gathered from the returned bronchoscope, the returned endotracheal tube and the test samples; the most probable cause for the customer's bronchoscope distal tip detaching when removed from the endotracheal tube, is likely due to a combination of the glidescope bflex 5.0 bronchoscope having insufficient adhesive applied to the distal tip end during its manufacturing, and the specific model endotracheal tube having a smaller than expected inner diameter causing higher-than-normal friction when the bronchoscope was passing through the endotracheal tube.The endotracheal tube used in the procedure has an inner diameter measuring at 5.0 mm, at the dorsal suction lumen, while the glidescope bflex 5.0 bronchoscope has a max outside diameter of 5.5 mm.Based off these measurements and the test samples run it was concluded that higher-than-normal resistance occurred in the following section of the tube.In verathon's glidescope bflex single-use bronchoscopes for glidescope core operation and maintenance manual (omm), verathon suggests on pg.16, "to lubricate the scope, tube or catheter if there is too much resistance." not using lubrication may have potentially played a factor if any higher-than-normal resistance was felt at the dorsal lumen section of the endotracheal tube when the bronchoscope was passing through.In april 2021 verathon implemented an update to the manufacture assembly instructions for the bronchoscope.These updated assembly instructions were made to implement a minor improvement to the application of glue and then lamination of the tip sheath to the camera housing, in accordance with the manufacturer's specifications.All manufacture operators for the glidescope bflex bronchoscope are currently operating under the following updated assembly instructions for the application of glue adhesive, which went into effect on april 12, 2021.While the lot number of the bronchoscope was not reported, verathon reviewed the shipping records for the glidescope bflex 5.0 bronchoscopes shipped to the customer's facility and determined the likely lot number used in the event was fs20150.This lot was manufactured prior to the assembly instruction updates, mentioned above.No corrective action is required at this time.Verathon will continue to monitor complaint data for any ongoing trends.

• Brand Name: GLIDESCOPE BFLEX 5.0 SINGLE-USE BRONCHOSCOPE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 13230826
• MDR Text Key: 288030416
• Report Number: 9615393-2022-00008
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 99 KG