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

Model Number 0574-0127

Device Problems Break (1069); Erratic or Intermittent Display (1182)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2020

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 was not working.A delay in the procedure of two (2) minutes occurred as a non-verathon device was obtained to complete the procedure.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10 the glidescope titanium lopro t4 was returned to verathon for evaluation.A verathon technical service representative evaluated the returned titanium lopro t4 and confirmed the intermittent image issue.The technical service representative noted that the image flickered and the monitor lost connection when the blade was manipulated.Visible corrosion on the pins was also noted.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 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 caused or contributed to the corrosion in the hdmi connector.Verathon followed up with the customer and restated the importance of blowing out the connectors following the reprocessing of the cable.

• 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: 10219664
• MDR Text Key: 197850559
• Report Number: 9615393-2020-00137
• 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: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 10/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1