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

Model Number 0600-0783

Device Problems No Display/Image (1183); Loose or Intermittent Connection (1371)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

The customer reported that during a patient procedure, using a glidescope video baton 2.0 large, the image on the screen disappeared and came on intermittently.The customer's biomed noted that the connection between the baton and cable seemed loose and was not very stable.A delay in the procedure of an undisclosed duration occurred as a backup glidescope avl device was obtained.No harm to the patient or user 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 glidescope core video baton 2.0 large was returned to verathon for evaluation along with the customer's glidescope core 10-inch monitor, glidescope core smart cable, and glidescope core quickconnect cable.A verathon technical service representative evaluated the returned devices and was able to confirm the reported image issue.The customer's glidescope core quickconnect cable was connected to known, good, verathon test equipment, and it was determined to be functioning as intended.They then connected the customer's video baton to a known, good, test smart cable and test monitor and the image was observed to be stable and clear.The customer's smart cable and video baton were then connected by the verathon technical service representative to a known, good, test monitor and the image would cut out when the connection between the customer's smart cable and video baton was manipulated.The verathon technical service representative last connected the customer's smart cable to a known, good, test video baton and test monitor and observed the image would continue to produce an intermittent image.On the customer's smart cable, the verathon technical service representative observed damage to the connector.The camera image quality test was performed and failed for the glidescope core smart cable.The customer's glidescope core 10-inch monitor, glidescope video baton 2.0 large, and glidescope quickconnect cable passed the camera image quality test and were all reported as functioning as intended.Upon completion of the evaluation, the glidescope core smart cable was scrapped, and the customer was provided a replacement glidescope core smart cable.The customer's glidescope core 10-inch monitor, glidescope video baton 2.0 large, glidescope quickconnect cable and replacement glidescope core smart cable were all returned back to the customer.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: 12780721
• MDR Text Key: 281395579
• Report Number: 9615393-2021-00341
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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: 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: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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