MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE VIDEO BATON 2.0 LARGE; LARYNGOSCOPE, RIGID

Model Number 0570-0382

Device Problem No Display/Image (1183)

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

Event Date 10/18/2022

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope core smart cable, the image disappears due to the smart cable and video baton detaching.The procedure was completed using a backup glidescope system, which was made available in an unspecified amount of time.No harm to the patient was reported.

Manufacturer Narrative

The device return is anticipated, however; at the time of the report the device has not been received by verathon.Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

The reported glidescope core smart cable was returned to verathon for evaluation along with the glidescope video baton 2.0 large used during the reported event.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.Upon visual inspection, damage was identified to the video baton's hdmi connector.When connecting the video baton to known, good, test verathon equipment, the led blinks and the image was blank.The video baton failed verathon's device functionality testing.The customer's smart cable passed both visual inspection and testing.The issue was isolated to just the glidescope video baton 2.0 large.The glidescope video laryngoscopes operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged." verathon followed up with the customer and restated the importance of checking the device before its use in a procedure.Upon completion of the device evaluation, the video baton was scrapped and the customer was provided a replacement.At the time of verathon's initial mdr submission, the glidescope core smart cable was suspected as being the faulty component.This follow-up/final mdr includes the device serial information for the glidescope video baton 2.0 large that was confirmed to be the faulty component.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE VIDEO BATON 2.0 LARGE
• 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: 15798181
• MDR Text Key: 307995753
• Report Number: 9615393-2022-00189
• 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,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0570-0382
• Device Catalogue Number: 0570-0398
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• 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