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

Model Number 0800-0601

Device Problem No Display/Image (1183)

Patient Problem Death (1802)

Event Date 06/05/2020

Event Type  Death  

Manufacturer Narrative

The glidescope core system (glidescope core 15 inch monitor, glidescope core onetouch cable, and glidescope video baton 2.0 large) was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope core system and observed a no image / intermittent image issue.Technical services noted that the glidescope core monitor and glidescope video baton functioned as expected.They attributed the issue to the glidescope core onetouch cable.The glidescope core system was forwarded to verathon (b)(4) for further investigation.The investigation at verathon (b)(4) confirmed the glidescope core monitor and glidescope video baton functioned as expected.Based on symptoms seen with the glidescope core onetouch cable, verathon (b)(4) determined that the failure matched the potential intermittent or complete loss of image as identified in previous investigations.As this failure was previously investigated, no further investigation for this cable was conducted.Verathon is conducting a voluntary recall of all glidescope core onetouch smart cables due to potential intermittent or complete loss of image during use.The customer was notified of the recall and was provided a compatible alternative replacement cable.

Event Description

The customer reported that the patient presented in the emergency room unresponsive.During the attempted intubation, using a glidescope core system, once the baton entered the airway, the screen flickered.The baton was adjusted but as it went into the airway again, the "screen showed nothing." the customer stated that an unspecified error message was displayed on the core video monitor.A delay of fifteen (15) minutes occurred as a back-up device was retrieved from the operating room; however, while the backup device was being obtained, the patient passed away.In a follow up call with the verathon regional manager, the customer restated that the patient was unresponsive upon arriving in the emergency department and indicated that the patient outcome was not related to the device malfunction.

• Brand Name: GLIDESCOPE CORE ONETOUCH 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 ; 6295760
• MDR Report Key: 10192945
• MDR Text Key: 196381785
• Report Number: 9615393-2020-00140
• 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: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0800-0601
• Device Catalogue Number: 0800-0601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 85705
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 91