MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE; BRONCHOSCOPE, FLEXIBLE OR RIGID

Model Number	0570-0374
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope bflex 5.0 single-use bronchoscope was received by verathon inc but has not been analyzed yet.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 or Problem Description
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.
Additional Manufacturer Narrative
D9, g3, g6, h2, h3, h6, h10 the glidescope bflex 5.0 bronchoscope used in the procedure was returned to verathon for evaluation.A visual inspection confirmed the tip sheath pebax material had been degraded and had been torn off the distal end of the bronchoscope camera housing.It was noted that the pebax material on the tip sheath could be rubbed off with a gloved hand.Following a similar event at the facility (see manufacture report number 9615393-2021-00235) information about the storage conditions of the bronchoscopes was requested.The customer was uncertain of the storage conditions of the bronchoscope used in this event; however, the current storage conditions were documented by the facility by providing photographs.While the exact storage conditions of this device could not be confirmed, the current storage conditions suggest that the device may have been stored in direct sunlight with exposure to ultraviolet (uv) light.In an effort to recreate the issue noted on the return samples, device samples were placed in a 405 nm led uv curing chamber for 28 minutes.The material flaking was duplicated following the exposure to the uv light.Verathon continues to investigate the reported event and will submit a supplemental follow up in accordance with 21 cfr 803.56 when additional information becomes available.

• Brand Name: GLIDESCOPE BFLEX 5.0 BRONCHOSCOPE
• Common Device Name: BRONCHOSCOPE, FLEXIBLE OR RIGID
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 11304127
• Report Number: 9615393-2021-00004
• Device Sequence Number: 4831322
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS193900(17)210228
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K183256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS200900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1