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

Model Number 0600-0783

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

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

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The glidescope core smart cable was returned to verathon for evaluation along with the corresponding glidescope core 15 inch monitor.A verathon technical service representative evaluated the returned smart cable and confirmed the reported issue of no image / intermittent image.On visual inspection, corrosion was observed on the pins of the hdmi connector.The verathon technical service representative also evaluated the glidescope core 15 inch monitor but was unable to confirm the reported issue; the monitor functioned as intended.On completion of the evaluation, the glidescope core smart cable was replaced and the returned smart cable was scrapped.The replacement glidescope core smart cable and the glidescope core 15 inch monitor were returned to the customer on completion of the evaluation.Corrective action is not required at this time.Verathon will continue to monitor for trends.The glidescope and gliderite products reprocessing manual states: "use hospital-grade clean air to blow remaining moisture out of the connectors, and then dry the component using either hospital-grade clean air or a clean, lint-free cloth." it is likely that not blowing out the connector with hospital-grade air caused or contributed to the corrosion in the hdmi connector on the glidescope core smart cable.Verathon followed up with the customer and restated the importance of blowing out the connectors following the reprocessing of the cable.

Event Description

The customer reported that during an emergency care procedure, using a glidescope core smart cable, the screen "blacked out" when the single-use blade was inserted into the patient's mouth.The physician withdrew the single-use blade and reinserted it into the patient's mouth and the screen "blacked out" again.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

• Brand Name: GLIDESCOPE CORE 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: 11060819
• MDR Text Key: 224637967
• Report Number: 9615393-2020-00264
• 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: 11/30/2020

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: 0600-0783
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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