MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4 VIDEO LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number 0574-0188

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

Patient Problems Laceration(s) (1946); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Neither the reported glidescope spectrum single-use directview mac s4 video laryngoscope nor the gliderite rigid stylet were made available to verathon for evaluation.Since the devices were not returned to verathon for evaluation, the exact cause of the reported patient injury could not be confirmed.The literature article discusses how "soft tissue injuries [using video laryngoscopes] commonly occur when the intubating physician concentrates on the video monitor and blindly inserts the glidescope® into the oropharynx.Advancing the ett into the patient's oral cavity and looking at the vl display creates a "blind spot" in the oropharynx, where the ett cannot be seen until it is imaged in the camera's view." furthermore, the article states "the use of rigid stylets, such as the gliderite®, significantly increases the risk of damage to upper airway structures.In our case, the injury could have been due to repetitive laryngoscopy attempts, as the glidescope® vl is very pointy and blunt.However, no bleeding was observed while the vl was in the oral cavity.One possibility is that the injury could have occurred while the vl was being removed from the mouth." while it was not confirmed if the reported patient injury was caused by the video laryngoscope, ett, or rigid stylet, verathon's instructions for use (ifu) instructs users to insert the blade and ett by looking in the patient's mouth rather than the video monitor screen.It is possible that the reported patient injury was due to the user not following verathon's ifu and blindly inserting the video laryngoscope and/or ett with the stylet while looking at the video monitor screen.Also, it was reported in the literature article that the patient presented with a difficult airway and required three intubation attempts by the user to successfully secure the airway.Verathon has followed up with the facility to discuss the reported incident and confirm that users are properly trained to perform intubations with verathon products in accordance with the ifu.To date, verathon has not received any response from the facility.Review of the facility's complaint history in the past five years did not identify any previous complaints reported to verathon.Trending analysis for glidescope spectrum single-use directview mac video laryngoscopes does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

Literature review of the pubmed database found a case report published on july 10, 2023 in the national library of medicine which reported that during a tracheal intubation, using a glidescope spectrum single-use directview mac s4 video laryngoscope, the patient experienced right tonsillar capsule perforation.It was reported that the tracheal intubation was attempted using an 8 mm outer diameter cuffed endotracheal tube (ett) shiley hi-lo oral/nasal tracheal tube with the glidescope video laryngoscope.The ett could not be passed successfully on the first or second attempts but was passed successfully through the vocal cords on the third attempt using a gliderite rigid stylet.At the end of the procedure, oropharyngeal suctioning before tracheal extubation returned a significant volume of fresh blood.Examination of the patient's oral cavity with a direct laryngoscope showed the right tonsillar capsule perforation.An otolaryngologist secured hemostasis by cauterizing and applying sutures to the lesions.The patient was extubated uneventfully after observation for half an hour.Follow-up on the 10th day confirmed that the laceration had healed without any residual damage.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE DIRECTVIEW MAC S4 VIDEO LARYNGOSCOPE
• 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: 17760878
• MDR Text Key: 323576166
• Report Number: 9615393-2023-00171
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 0574-0188
• Device Catalogue Number: 0270-0933
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/15/2023
• 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; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male