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

Model Number 0574-0195

Device Problem Insufficient Information (3190)

Patient Problem Laceration(s) (1946)

Event Date 05/01/2022

Event Type  Injury  

Event Description

A customer reported that during a patient procedure, using glidescope spectrum single-use lopro s4 larygnoscopes, the patient received a laceration and was bleeding at the top of the mouth/soft pallet.Despite numerous follow-up attempts sent to the customer, no further information was made available regarding the patient injuries or subject devices used during the reported events.It is unknown if medical intervention was required for the patients.The exact cause of the reported lacerations remains unknown.

Manufacturer Narrative

The glidescope spectrum single-use lopro s4 laryngoscopes used during the procedures were not returned to verathon for investigation.Verathon attempted to obtain additional information regarding the reported patient events, but to date has not received any additional information from the customer.Based on the information initially reported, there is no evidence suggesting that a device malfunction occurred leading to the reported lacerations.While the cause could not be fully determined, there is potential that the reported events were due to inadequacy in user training by the healthcare professional(s) performing the procedures.Verathon's glidescope video laryngoscopes operation & maintenance manual (omm) provides a notice to all users, which states: "these [device] components 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." if further training assistance is found necessary outside of what is listed in the omm, verathon is committed to partnering with clinicians and hospital systems to ensure support of training through the use of labeling, videos, in-person support, and airway workshops/training days.Verathon has followed-up and communicated with the customer about their questions for preventing injuries following the reported events.At this time corrective action is not required.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM SINGLE-USE LOPRO S4
• 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: 15695062
• MDR Text Key: 302688696
• Report Number: 9615393-2022-00197
• 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: Physician
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0574-0195
• Device Catalogue Number: 0270-0939
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• 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