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

Model Number 0800-0602

Device Problems Corroded (1131); Erratic or Intermittent Display (1182)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2020

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

The customer reported that during a patient procedure, using a glidescope core smart cable, the core camera image was going in and out.It was noted that the connector for the smart cable was rusted.A delay in the procedure of an unknown duration occurred as another glidescope core was obtained.No harm to the patient or user was reported.

Manufacturer Narrative

The glidescope core smart cable was returned to verathon for evaluation.A verathon technical service representative evaluated the returned glidescope core smart cable and confirmed the intermittent image issue.When the baton was manipulated, the image cut in and out.Corrosion was observed on the pins inside the hdmi connector which likely caused the image issue.No corrective action is required at this time.Verathon will continue to monitor for trends.The glidescope video laryngoscopes operations and maintenance manual (omm) states: "using hospital-grade clean air, which is free from oils and residuals found in common compressed air, blow out the connectors.This dries the connectors and removes any remaining residuals." it is likely that not blowing out the connector with hospital-grade air caused or contributed to the corrosion in hdmi connector.Verathon followed up with the customer and restated the importance of blowing out the connectors following the reprocessing of the blades.

• 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
• MDR Report Key: 10009592
• MDR Text Key: 190009398
• Report Number: 9615393-2020-00082
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0800-0602
• Device Catalogue Number: 0800-0602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1