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

Model Number	0570-0374
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glidescope bflex 5.0 single-use bronchoscope was received by verathon inc on 30 jul 2020 but has not yet been analyzed.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 single-use bronchoscope, the device would not generate an image.It was reported that other bronchoscopes in the same box were working fine.An unspecified delay in the procedure occurred as another glidescope bflex 5.0 bronchoscope was obtained.No harm to the patient or user was reported.
Additional Manufacturer Narrative
D9, g3, g6, h2, h3, h6, h10 the glidescope bflex 5.0 single-use bronchoscope was returned to verathon for evaluation.A verathon technical service representative evaluated the returned bflex 5.0 and confirmed the no image issue.The technical service representative found that when the b-flex 5.0 was connected to a working core 10" monitor and a quickconnect cable, the light powered on briefly but stopped working within five (5) seconds.The core 10" monitor indicated a user camera attachment was needed even though the bflex 5.0 was securely attached.The glidescope bflex 5.0 bronchoscope was sent to engineering for further investigation.Further investigation confirmed the core 10" monitor was unable to receive a video feed from the glidescope bflex 5.0 via the quickconnect cable even though the bflex was receiving power from the core 10" monitor as the led tip was turned on for a short period.The root cause of the customer complaint is due to a defective onanon receptacle component that has pin 5 and pin 6 soldered together on the receptacle's pcba.This problem has been deemed to have a risk rating of r1 which is an acceptable risk.

• Brand Name: GLIDESCOPE BFLEX 5.0 SINGLE-USE 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: 10420106
• Report Number: 9615393-2020-00156
• Device Sequence Number: 14200824
• Product Code: EOQ
• UDI-Device Identifier: 00879123006332
• UDI-Public: (01)00879123006332(10)FS202001(17)210515
• Combination Product (Y/N): N
• 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): 07/21/2020

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: 05/15/2021
• Device Model Number: 0570-0374
• Device Catalogue Number: 0570-0375
• Device Lot Number: FS202001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1