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

Model Number	0600-0783
Medical Device Problem Codes	Erratic or Intermittent Display (1182); No Display/Image (1183); Display or Visual Feedback Problem (1184); Poor Quality Image (1408); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during an emergency care procedure, using a glidescope core smart cable, the doctor had difficulty plugging in a glidescope spectrum single-use lopro s3 laryngoscope.Once the laryngoscope was forcefully connected, there was no image displayed, only a black screen.Another lopro s3 laryngoscope was obtained and the image was dark.As the doctor entered the patient's airway, the image was dim but once the laryngoscope was advanced further, the light went out.The procedure was completed with a backup core system utilizing a bflex 2 single-use bronchoscope and a glidescope spectrum single-use lopro s3 laryngoscope, however the lighting was also dark and difficult to see for both.No delay in the procedure or harm to the patient was reported.
Additional 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 along with a glidescope core 2m quickconnect cable and eight (8) glidescope spectrum single-use lopro s3 laryngoscopes.A verathon technical service representative (tsr) evaluated the returned smart cable and was able to confirm the reported cable failure.When connected to verathon's known, good, test equipment, the smart cable produced split screen and the image intermittently cut out.The customer's smart cable failed verathon's device functionality testing.Next, the verathon tsr evaluated the returned glidescope core 2m quickconnect cable but was found to be working as intended.When connected to verathon's known, good, test equipment, no light was observed cutting out or dimming.Next, the verathon tsr evaluated the returned glidescope spectrum single-use lopro s3 laryngoscopes and confirmed that they were difficult to attach to the test cable.When connected to verathon's known, good, test equipment, the laryngoscopes were found to be working as inteneded with no dimming, image dropping, or light cutting out.Upon completion of verathon's device evaluation, the customer's glidescope core smart cable and glidescope spectrum single-use lopro s3 laryngoscopes were scrapped due to the customer already being provided with replacements and there being no repairs available for the devices.The customer's glidescope core 2m quickconnect cable was returned to their facility.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE CORE SMART CABLE
• Common Device Name: 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: 19702377
• Report Number: 9615393-2024-00098
• Device Sequence Number: 20763370
• Product Code: CCW
• UDI-Device Identifier: 00879123006509
• UDI-Public: 010087912300650911240423
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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
• Operator of Device: 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: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown