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

Model Number	0600-0771
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that during a patient procedure, using a glidescope core video cable, loose contact caused the picture to go out intermittently even though the video cable and laryngoscope were connected properly.The customer reported isolating the issue to just the video cable.No delay in the procedure, use of a backup device, or harm to the patient was reported.
Additional 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.
Additional Manufacturer Narrative
The glidescope core video cable used during the reported incident was returned to verathon for evaluation along with another glidescope core video cable from the facility.A verathon technical service representative evaluated the returned video cables and was able to confirm the reported image issue with one of the cables.The first video cable evaluated showed no visible damage; however, when connected to known, good, test verathon equipment, intermittent loss of image was observed.This video cable failed verathon's device functionality testing.The second video cable evaluated showed physical damage to the connector.When connected to known, good, test verathon equipment, it functioned as intended with no loss of image observed.Upon completion of verathon's device evaluation, the customer was notified about verathon's evaluation findings and recommended replacing their glidescope core video cables.Corrective action is not required at this time.Verathon will continue to monitor for trends.
Additional Manufacturer Narrative
This is a supplemental report correcting the unique device identifier (udi) information in section d4.In the initial report submission, the udi information field was left blank due to the subject device lot number and manufacture date being unknown.Despite verathon being unable to obtain the lot information from the customer, this supplemental report provides the udi-di for the subject device model.

• Brand Name: GLIDESCOPE CORE VIDEO 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: 18357756
• Report Number: 9615393-2023-00229
• Device Sequence Number: 17751557
• Product Code: CCW
• UDI-Device Identifier: 00879123006547
• UDI-Public: (01)00879123006547
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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: 0600-0771
• Device Catalogue Number: 0800-0604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 02/05/2024; Not provided
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/13/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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