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

Model Number 0800-0543

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

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

Event Date 11/24/2020

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.

Event Description

The customer reported that during a patient procedure, using a glidescope spectrum smart cable, when the blade was put in the patient's mouth, the screen went black.Once the blade was removed, the image was normal again.When the blade was reintroduced into the patient's mouth, the screen went black.No delay in the procedure, use of a backup device, or harm to the patient or user was reported.

Manufacturer Narrative

Although the initial event reported was that a glidescope spectrum smart cable (0800-0543, sd191326) was experiencing a no image issue, spectrum smart cable (0800-0543, sd172243) was returned instead.When the returned spectrum smart cable was connected to a test single use blade and then later with a video baton 2.0, the cable was not recognized.The malfunction was isolated to the cable.The customer was advised that the problem was isolated to the smart cable and that it was unrepairable.It should be noted that the glidescope spectrum smart cable used in the procedure was not returned to verathon for evaluation; therefore, the root cause could not be conclusively determined.The customer requested that the glidescope spectrum smart cable be returned to them as-is.Corrective action is not required at this time.Verathon will continue to monitor for trends.

• Brand Name: GLIDESCOPE SPECTRUM 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: 11060828
• MDR Text Key: 239206412
• Report Number: 9615393-2020-00267
• 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: 12/01/2020

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: 0800-0543
• Device Catalogue Number: 0800-0544
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1