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

Model Number 0600-0767

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The glidescope core quickconnect cable was returned to verathon for evaluation.A verathon technical service representative evaluated the returned core quickconnect cable and could not reproduce the image issue; the unit functioned as intended.The glidescope core quickconnect cable was scrapped and a replacement was sent to the customer.No further investigation is required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during an emergency procedure, using a glidescope core quickconnect cable, the image was really dark and there were dark spots in the image.By exchanging cables, the customer isolated the problem to the cable.A delay of one (1) to two (2) minutes occurred as a competitor's product was obtained to finish the procedure.No harm to the patient or user was reported.

• 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: 11060979
• MDR Text Key: 225185268
• Report Number: 9615393-2020-00278
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2020

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: 14739-2-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• 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