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

Model Number 0800-0543

Device Problem No Display/Image (1183)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

The customer declined the option to have their glidescope spectrum smart cable returned to verathon for evaluation.Since the device was not returned to verathon for evaluation, the cause could not be determined.Based on communication with the customer, the likely cause of the reported issue was isolated to just the glidescope spectrum smart cable.Review of complaint history for the reported smart cable serial number "(b)(4)" did not identify any previous complaints reported to verathon.Trending analysis for the glidescope spectrum smart cables does not identify any trends exceeding acceptable limits.Review of the system risk assessment confirmed that the risk associated with the hazardous scenario has been adequately captured and characterized.Verathon recommended the customer replace their glidescope spectrum smart cable as there are currently no repairs available for this device.Corrective action is not required at this time.Verathon will continue to monitor for trends.

Event Description

The customer reported that during a patient procedure, using a glidescope spectrum smart cable, the image disappears.The customer was able to complete the procedure by holding the cable in position during the procedure.No delay in the procedure, use of a backup device, or harm to the patient was reported.

Manufacturer Narrative

The customer who had originally declined the option to have their glidescope spectrum smart cable returned to verathon for evaluation, did eventually return the following smart cable to verathon and a replacement smart cable was provided to the customer.A verathon technical service representative evaluated the reported smart cable and confirmed the reported image issue.When connecting the reported smart cable to known, good, test verathon equipment, the image from the test video monitor would intermittently disappear.When an image did appear the test monitor displayed green lines.Upon visual inspection the verathon technical service representative reported the smart cable's hdmi connector pins had residue inside.The camera image quality test was performed and failed for the glidescope spectrum smart cable.Upon completion of the evaluation the reported glidescope spectrum smart cable was scrapped as it had already been replaced prior to its return to verathon, and there being no repairs available for this device.Corrective action is not required at this time.Verathon will continue to monitor for trends.The glidescope and gliderite products reprocessing manual states: "use hospital-grade clean air to blow remaining moisture out of the connectors, and then dry the component using either hospital-grade clean air or a clean, lint-free cloth." it is likely that not blowing out the connector with hospital-grade air or drying the connector with a clean, lint-free cloth may have caused or contributed to the residue in the hdmi connector.Verathon followed up with the customer and restated the importance of drying the connectors following the reprocessing of the smart cable.

• Brand Name: GLIDESCOPE SPECTRUM 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: 15753239
• MDR Text Key: 305244400
• Report Number: 9615393-2022-00199
• 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: 10/31/2022

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
• Device Operator: Health Professional
• Device Model Number: 0800-0543
• Device Catalogue Number: 0800-0544
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/18/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• 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