MAUDE Adverse Event Report: VERATHON INC. GLIDESCOPE; LARYNGOSCOPE, RIGID

Model Number 0574-0195

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 07/23/2021

Event Type  malfunction  

Event Description

Narrative from staff: went to use the glidescope and the light source in the glidescope was not working therefore inhibiting the er provider from seeing the vocal cords to place et tube.Patient had already received sedation and paralytic medications.The patient fortunately was able to be intubated before any negative event.This could have caused patient decompensation.After replacing the intubation blade, it was determined that the lopro 4 blade was defective.

• Brand Name: GLIDESCOPE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): VERATHON INC.; 20001 north creek pkwy; bothell WA 98011
• MDR Report Key: 12287310
• MDR Text Key: 265377843
• Report Number: 12287310
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0195
• Device Catalogue Number: 0574-0195
• Device Lot Number: GU75899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 84