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

Model Number 0800-0601

Device Problems Erratic or Intermittent Display (1182); Incomplete or Inadequate Connection (4037)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

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.Verathon incorporated is conducting a voluntary recall of all glidescope core onetouch smart cables due to potential intermittent or complete loss of image during use.The customer was notified of the recall and provided a compatible alternative replacement cable.

Event Description

The customer reported that during a emergency patient procedure, using a glidescope core onetouch smart cable, the device was consistently indicating that the cable was not connected.It was also noted that the quick connect portion of the cable was rattling.A delay of at least ten (10) minutes occurred while a back-up gvm device was obtained.No harm to the patient or user was reported.

Manufacturer Narrative

The glidescope core onetouch smart cable was returned to verathon for destruction and disposal.Previous investigations at verathon canada of glidescope core onetouch smart cables were able to duplicate the reported intermittent image issue.Verathon's investigation determined that when the user applies a twisting motion while attempting to connect the blade in the hdmi port or applies excessive torsion to the connection port (adjacent to the video capture / record buttons), this force is transferred from the hdmi connector port to the hdmi printed circuit board (pcb), which controls the video signal.As a result, there is an interruption in the video synchronization signal.This causes a temporary loss of the live image.As a result, the user may experience an intermittent image or "blank screen." in some cases, the monitor will display the "no cameras connected" monitor warning.Verathon incorporated is conducting a voluntary recall of all glidescope core onetouch smart cables due to potential intermittent or complete loss of image during use.The customer was notified of the recall and provided a compatible alternative replacement cable.

• Brand Name: GLIDESCOPE CORE ONETOUCH 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: 10146608
• MDR Text Key: 195988936
• Report Number: 9615393-2020-00124
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0800-0601
• Device Catalogue Number: 0800-0601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 85705
• Patient Sequence Number: 1