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

Model Number 0800-0544

Device Problems Erratic or Intermittent Display (1182); Intermittent Loss of Power (4016)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2020

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 spectrum smart cable, there was an intermittent image.The customer could move the cable and sometimes obtain an image but not always.There was no visible damage to the cable.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 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 when the cable was torqued/twisted near the hdmi plug.The technician also noted that the cable was crimped/damaged near the hdmi plug.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: SPECTRUM SMART CABLE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, british columbia V5C 5 A9; CA V5C 5A9
• MDR Report Key: 10070762
• MDR Text Key: 191898050
• Report Number: 9615393-2020-00108
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0800-0544
• Device Catalogue Number: 0800-0544
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1