MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE CORE 2M QUICKCONNECT CABLE; LARYNGOSCOPE, RIGID

Model Number 0600-0843

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

A customer reported that during an emergency care procedure of a pediatric patient, using a glidescope core 2m quickconnect cable, the image flickered when connecting the cable to a glidescope spectrum single-use quickconnect hyperangle s3 laryngoscope.They disconnected and reconnected the cable which they reported appeared to be working fine.However, they went to intubate the patient and lost the total image.The procedure was completed using a backup cable which was made readily available.No delay in procedure or harm to the patient was reported.

Manufacturer Narrative

A replacement glidescope core 2m quickconnect cable was provided to the customer and the cable used during the reported incident was returned to verathon for evaluation.A verathon technical service representative evaluated the returned cable but was unable to confirm the reported image issue.When connected to verathon's known, good, test equipment, no flickering image was observed.The cable was tested on both monitor ports a and b using a single-use blade and bronchoscope.No failures were observed during the testing.No physical damage was observed to the cable as well.The customer's glidescope core 2m quickconnect cable passed verathon's device functionality testing.Neither the glidescope core 15-inch fhd monitor nor the glidescope spectrum single-use quickconnect hyperangle s3 laryngoscope used with the cable during the reported incident were made available to verathon for evaluation.Upon completion of verathon's device evaluation, the cable was scrapped due to the customer already being provided a replacement.No further investigation is required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE 2M 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: 19165149
• MDR Text Key: 341485786
• Report Number: 9615393-2024-00065
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2024

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: 0600-0843
• Device Catalogue Number: 0800-0682
• Device Lot Number: 17400-2-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2023
• 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