MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.8 SINGLE-USE BRONCHOSCOPE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number 0570-0381

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

Verathon reviewed the device history record (dhr) for the reported glidescope bflex 5.8 single-use bronchoscope lot number "ft214900" and trending analysis for the glidescope bflex single-use bronchoscope did not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.The reported glidescope bflex 5.8 single-use bronchoscope was received by verathon for investigation.A verathon technical service representative performed a visual inspection of the returned bronchoscope and confirmed the reported damage.The reported glidescope bflex 5.8 single-use bronchoscope was then forwarded to a verathon sustaining engineering representative for further investigation.If more information becomes available for the following device investigation a supplemental report will be submitted in accordance with 21 cfr 803.56.Verathon will continue to monitor for any ongoing trends.

Event Description

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.

Manufacturer Narrative

Additional evaluation of the returned glidescope bflex 5.8 single-use bronchoscope was performed by a verathon sustaining engineering representative.Upon visual inspection of the device, the engineer noted that the camera assembly and distal coupler were missing, the bundle wire was severed, the distal tip sheath was ripped, and the working channel was stretched out.The proximal coupler and proximal tip sheath were intact and there was no evidence of proximal tip sheath roll back.The rib of the articulating tip above the proximal coupler also appeared damaged.A possible conclusion for the damage found to the bronchoscope could have been caused by regions inside the ett used which may not have been smooth.During the bronchoscope maneuvering in the ett the bronchoscope tip sheath may have sustained damage initiating a tear.The exposed metal observed may have gotten caught on the edges of the ett preventing it from either advancing smoothly through the bronchoscope or retracting appropriately.It is possible that the bronchoscope was pulled forcibly when attempting to retrieve/dislodge it from the ett causing the bronchoscope tip sheath to tear further, stretching the working channel, and eventually fraying the working channel and severing it and its wire bundle.Thus, resulting in the observed separation of the bronchoscope camera subassembly unit at the distal coupler.While the exact root cause of the reported issue could not be fully determined, based on the identified damage found during the investigation, the most plausible cause of failure for the bronchoscope was damage caused to the bronchoscope while attempting to maneuver it inside the ett.The distal tip had most likely separated due to forcible attempt(s) while attempting to retrieve the bronchoscope from the ett.At this time corrective action is not required.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE BFLEX 5.8 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: 15709792
• MDR Text Key: 307287869
• Report Number: 9615393-2022-00179
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 10879123006407
• UDI-Public: 011087912300640710FT214900172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT214900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• 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