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

Model Number 0800-0543

Device Problems Erratic or Intermittent Display (1182); Electrical /Electronic Property Problem (1198)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device return is anticipated, however, at the time of the report the devices have 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 glide scope spectrum smart cable, the image would disappear intermittently, the customer claimed an alleged cable fault.No delay in the procedure, use of a backup device, or harm to the patient, or user was reported.

Manufacturer Narrative

The spectrum smart cable was returned to verathon for evaluation.A verathon technical service representative evaluated the returned spectrum smart cable and confirmed the reported intermittent image issue.The technical service representative stated that the video feed was intermittent when the cable was manipulated.The fault appeared to be an internal wiring fault near the hdmi connector.The spectrum smart cable was scrapped and a replacement was sent to the customer.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: 10779492
• MDR Text Key: 218991760
• Report Number: 9615393-2020-00223
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

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: 11/12/2020
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1