MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE QUICKCONNECT CABLE; LARYNGOSCOPE, RIGID

Model Number 0600-0767

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have the reported glidescope core quickconnect cable returned to verathon for evaluation after isolating the issue to the cable.Since the device was not returned to verathon for evaluation, the cause could not be determined.A complaint history search could not be performed for the reported glidescope core quickconnect cable due to the lot number not being provided to verathon.Trending analysis for the glidescope core quickconnect cables 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 by verathon.The customer reported replacing the subject glidescope core quickconnect cable following the reported event.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

Event Description

A customer reported that during an emergency care procedure, using a glidescope core quickconnect cable, black and grey scrambled lines appeared on the glidescope core 15-inch monitor when a glidescope bflex 5.8 single-use bronchoscope was connected.A different glidescope bflex 5.8 single-use bronchoscope was connected to the cable and monitor but the black and grey scrambled lines appeared again repeatedly after the bronchoscope was placed into the patient's airway.The procedure was completed using a different glidescope core system with the same bronchoscope used on the patient previously.No delay in the procedure or harm to the patient was reported.Follow-up information received from the customer reported that they were able to isolate the issue to the glidescope core quickconnect cable that was used with the initial monitor and bronchoscope.

• Brand Name: GLIDESCOPE CORE QUICKCONNECT CABLE
• 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: 18184380
• MDR Text Key: 328696827
• Report Number: 9615393-2023-00215
• 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: 10/27/2023

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: 0600-0767
• Device Catalogue Number: 0800-0605
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1