MAUDE Adverse Event Report: VERATHON MEDICAL (CANADA) ULC. GLIDESLOPE SPECTRUM SINGLE-USE VIDEO LARYNGOSCOPE; LARYNGOSCOPE, RIGID

Model Number LOPRO S3

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2021

Event Type  Injury  

Event Description

Glideslope spectrum single-use video laryngoscope.We have had several equipment failures with the scope.It is a replacement and "upgrade model" from the previous version.Intubations in the emergency department are extremely time sensitive given that the patients are sedated and paralyzed with medications prior to the procedure starts.In this particular case, a critical patient with a gunshot wound who needed emergency intubation, the glide scope failed during the procedure.It seemed to be working prior to the procedure but when the handle was manipulated the video signal would cut out.I believe part of the air is that in this new model, there is a connection between the cable and the laryngoscope handle with the plug similar to a usb-type plug.It is very motion sensitive and very prone to failure.The disappointing thing is that this piece of malfunctioning equipment had just come back from the manufacturer after having the same problem, and according to them it had been "checked and they could not find any malfunctions" this particular case was an extremely close call because we needed to get back up equipment for this equipment failure.Fortunately, the patient lived but it was a very close call.Fda safety report id# (b)(4).

• Brand Name: GLIDESLOPE SPECTRUM SINGLE-USE VIDEO LARYNGOSCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON MEDICAL (CANADA) ULC.; bothell WA 98011
• MDR Report Key: 12016471
• MDR Text Key: 257432157
• Report Number: MW5101936
• Device Sequence Number: 1
• Product Code: CCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021

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
• Device Operator: Health Professional
• Device Model Number: LOPRO S3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR
• Patient Weight: 75