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

Model Number	0570-0381
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported glidescope bflex 5.8 single-use bronchoscope and its broken tip were returned to verathon for evaluation along with the ett and lubricant used during the procedure.A verathon technical service representative (tsr) evaluated the returned bronchoscope and confirmed the reported tip detachment.Upon visual inspection, the tsr noted that the tip was in pieces and the camera was not attached.While the exact cause of the tip detachment could not be determined, it is likely that the cause was due to inserting the glidescope bflex 5.8 single-use bronchoscope into the "kinked" covidien-shiley hi-lo oral/nasal trachel tube.Review of complaint history for the reported lot number "ft230400" does not identify any previous complaints reported to verathon.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized by verathon.Trending analysis for the glidescope bflex 5.8 single-use bronchoscopes does not identify any trends exceeding acceptable limits.Upon completion of the evaluation, the reported glidescope bflex 5.8 single-use bronchoscope was scrapped as it is a single use device and there being no repairs available for this device.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Event or Problem Description
A customer reported that during a tracheostomy with bronchoscopy procedure, using a glidescope bflex 5.8 single-use bronchoscope, a piece of the bronchoscope camera/tip broke off into the patient's right bronchus.The bronchoscope tip broke when being retracted after multiple attempts from a size 8.0 mm covidien shiley hi-lo oral/nasal tracheal tube.The physician noted that there was a "kink" with the ett at the beginning of the case.It was reported that medline lubricating jelly was used with the bronchoscope and liberally applied consistent with other bronchoscopy procedures.The bronchoscope tip was successfully retrieved from the patient which increased the procedure time by 20-30 minutes.No harm to the patient was reported.

• Brand Name: GLIDESCOPE BFLEX 5.8 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
• 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: 17343380
• Report Number: 9615393-2023-00124
• Device Sequence Number: 6524495
• Product Code: EOQ
• UDI-Device Identifier: 10879123006407
• UDI-Public: 011087912300640710FT23040017240127
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K191948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 0570-0381
• Device Catalogue Number: 0570-0397
• Device Lot Number: FT230400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown