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

Model Number 0600-0783

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371)

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

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to verathon, however at the time of this report, the device has not yet been evaluated.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 connection at the hdmi end was "loose".As a result, the image would become pixilated and blurry.The healthcare professionals completed the procedure by performing a direct laryngoscopy on the patient.No harm to the patient or user was reported.

Manufacturer Narrative

D9, g3, g6, h2, h3, h6, h10.The glidescope core smart cable was returned to verathon for evaluation.A verathon technical service representative evaluated the returned core smart cable and noted damage to the hdmi connector.The glidescope core smart cable was scrapped and a replacement smart cable was sent to the customer.No corrective action is required at this time.Verathon will continue to monitor for trends.The glidescope operations and maintenance manual (omm) notes that "before every use, ensure that the instrument is operating correctly and has no sign of damage.Do not use this product if the device appears damaged.".

• 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: 10901151
• MDR Text Key: 225596235
• Report Number: 9615393-2020-00236
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 11/16/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 MO