MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE SPECTRUM SMART CABLE; LARYNGOSCOPE, RIGID

Model Number 0800-0543

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope spectrum smart cable, the image intermittently disappeared when the device was manipulated.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

A replacement glidescope spectrum smart cable was provided to the customer and the reported glidescope spectrum smart cable used during the procedure was returned to verathon for evaluation.A verathon technical service representative evaluated the returned smart cable and was able to confirm the reported image issue.When connecting the reported glidescope spectrum smart cable to known, good, test verathon equipment, the cable failed to be recognized and showed rainbow-colored static.The customer's smart cable failed verathon's device functionality testing.Upon completion of the evaluation, the device was scrapped, due to the customer already being provided a replacement.Corrective action is currently not required at this time.Verathon will continue to monitor for any ongoing trends.

• Brand Name: GLIDESCOPE SPECTRUM SMART 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: 16496328
• MDR Text Key: 310863465
• Report Number: 9615393-2023-00036
• 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: 02/13/2023

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: 0800-0543
• Device Catalogue Number: 0800-0544
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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