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

Model Number UNKNOWN

Device Problems Break (1069); Material Separation (1562)

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

Event Date 02/25/2024

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

A customer reported that during a bronchoscopy, using a glidescope bflex 5.8 single-use bronchoscope (unknown model), the patient was light on anesthesia and woke up during the procedure.The patient bit down and severed the distal tip of the bronchoscope which fell off inside the endotracheal (et) tube.The customer was able to use forceps to retrieve the distal end of the bronchoscope from the et tube.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The reported glidescope bflex 5.8 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned device and was able to confirm that the distal tip was detached from the bronchoscope's sheath.Furthermore, it was identified that the flexible tube was flattened and pinched in multiple locations.The device evaluation findings were consistent with a patient biting down and severing the distal tip as initially reported by the customer.The glidescope bflex single-use bronchoscope operations & maintenance manual contains a caution stating: "do not use excessive force when inserting, positioning, or removing the single-use bronchosopce or accessories.Using excessive force against resistance could result in product damage, including damage to or detachment of the distal tip." upon completion of verathon's device evaluation, the bronchoscope was scrapped due to being single-use device and there being no repairs available.Corrective action is not required at this time.Verathon will continue to monitor for 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: 18980433
• MDR Text Key: 338623106
• Report Number: 9615393-2024-00049
• Device Sequence Number: 1
• Product Code: EOQ
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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