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

Model Number 0600-0783

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

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.

Event Description

A customer reported that during an emergency care procedure, using a glidescope core smart cable, the light went out on the connected glidescope spectrum single-use lopro laryngoscope.The screen on the connected glidescope core 15-inch fhd monitor went black, but after unplugging the cable and restarting the monitor it worked as intended.It was reported that the patient began desatting but the procedure was able to be completed using a direct laryngoscope which was made available after a couple of minutes.The customer reported isolating the issue to just the glidescope core smart cable.

Manufacturer Narrative

A replacement glidescope core smart cable was provided to the customer and the reported glidescope core smart cable used during the reported event was returned to verathon for evaluation.A verathon technical service representative (tsr) evaluated the returned smart cable and was able to confirm the reported cable failure.Upon visual inspection, the tsr identified damage to the smart cable's hdmi connector pins.Due to the damaged connector pins, the smart cable was unable to be connected to verathon's test equipment for functionality testing due to risk of damaging the test equipment.Despite being unable to perform functionality testing to confirm the reported image issue, it is likely that the damaged connector pins caused or contributed to the reported loss of light and black screen.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 verathon's device evaluation, the customer's smart cable was scrapped as it had already been replaced and there being no repairs available for the device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• 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: 17861327
• MDR Text Key: 324805557
• Report Number: 9615393-2023-00186
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 08791230067591
• UDI-Public: 0108791230067591123070321CA232394
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2023
• 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