MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE,TITANIUM, LOPRO,T4; LARYNGOSCOPE, RIGID

Model Number 0574-0127

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

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 titanium lopro t4, the blade would continually short out and the screen would go black.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

D10, g4, g7, h2, h3, h6 & h10.The glidescope titanium lopro t4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned titanium blade and confirmed the blade failure.The technician reported an intermittent image and stated that the blade connector was corroded.The glidescope titanium lopro t4 was scrapped and a replacement was sent to the customer.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 on the connector pins.Verathon followed up with the customer and restated the importance of blowing out the connectors following the reprocessing of the blades.

• Brand Name: GLIDESCOPE,TITANIUM, LOPRO,T4
• 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: 9820871
• MDR Text Key: 189991494
• Report Number: 9615393-2020-00041
• 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: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0574-0127
• Device Catalogue Number: 0574-0148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1