MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3; LARYNGOSCOPE, RIGID

Model Number 0574-0194

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

The customer declined the option to have their glidescope spectrum single-use lopro s3 returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.While the glidescope spectrum single-use lopro s3 was being used during the et tube placement at the time of the reported patient injury, there was no alleged device malfunction.The glidescope spectrum single-use lopro s3 utilizes dynamic light control technology to optimize image brightness and clarity throughout the intubation process, however verathon does not recommend users to continue advancing the et tube further into the patient's airway if experiencing a momentary glare or "white-out" view when the et tube passes by the camera.Advancing an et tube with no view has potential to cause patient injury which the customer reported occurring during this patient procedure event.Verathon's glidescope video laryngoscopes operations & maintenance manual (omm) provides a notice to all users, which states: "[glidescope systems] should be used only by individuals who have been trained and authorized by a physician or used by healthcare providers who have been trained and authorized by the institution providing patient care." "verathon recommends that all users read this manual before using these components.Failure to do so may result in injury to the patient, may compromise the performance of the system, and may void the system warranty.Verathon recommends that new glidescope users: obtain instruction from a qualified individual, practice using the system on a mannequin before clinical use and acquire clinical experience on patients without airway abnormalities." verathon has attempted to follow-up with the customer for additional information regarding the patient's condition and if any medical intervention was required but to date, no information has been received.If any new information becomes available regarding the patient's status or the reported device investigation, a supplemental/follow-up report will be submitted in accordance with 21 cfr 803.56.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glidescope spectrum single-use lopro s3, the light of the glidescope hit the et tube and produced a glare causing them to lose the view.It was reported that as they continued to advance the et tube further into the patient's airway with no view, they caused a mucosal injury in the patient's oral pharynx from the et tube.The current status of the patient remains unknown.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S3
• Type of Device: LARYNGOSCOPE, 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: 14754691
• MDR Text Key: 295030835
• Report Number: 9615393-2022-00112
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 0574-0194
• Device Catalogue Number: 0270-0938
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other