On 17-Jul-2020, US-FDA released a recall alert for class I medical Device- GlideScope Core One TouchSmart Cable (“OneTouch cable”) due to partial or complete loss of image during use.

Device Use:

The GlideScope Core Video Laryngoscopy System is intended to provide a clear view of the airway and vocal cords for medical procedures. The Core OneTouch Smart Cable is a part of the system and is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors.

Recall Reason:

The manufacturer of this medical device-Verathon Inc. has initiated recall because of the potential for temporary or complete loss of image when used with Core 10 and Core 15 video monitors. If there is an interruption in the video signal during use, this may cause the patient to experience serious adverse health consequences, including hypoxia and death.

Device Incident reports:

The manufacturer had received 74 Medical Device Incident Reports (MDIR) in total pertaining to these devices and the FDA has received 9 MDIR. However, there were no complaints which reported any injuries or deaths.

Class I Medical Device Recall:

This medical device falls under the category of Class I, as per the classification system by US-FDA. This is the most serious type of recall because use of these devices might cause serious injuries or death.

Recalled Devices:

On 06-May-2020, Verathon Inc. initiated the recall for 356 medical devices which were manufactured during 17-Sep-2019 to 22-Apr-2020 and distributed between 17-Jan-2020 and 22-Apr-2020. The model or catalog number for the affected medical device is Verathon, Inc. part number 0800‐0601. The product codes and lot numbers for this recalled product are CCW and Verathon, Inc. part number 0800‐0601.

Key information from Verathon Inc:

On 05-Jun-2020, the manufacturer has sent a Field Safety Notice (FSN) to affected customers (physicians using this medical device) to inform them about the issue and the following instructions were provided:

• Review the information contained within this Field Safety Notice with all staff members who should be aware of the contents of the Field Safety Notice.
• Locate all Core OneTouch Smart Cables in the facility.
• Discontinue use of all Core OneTouch Smart Cable(s).
  • Be aware that Core Smart Cable, Quick Connect Cable, and Core Video Cable can continue to be used with GlideScope products and do not require additional inspection.
• When replacements are received, destroy or return all Core One Touch Smart Cables.
• Complete the Recall Response Form (last page of the Field Safety Notice):
  • Answer all four (4) questions by checking the appropriate box.
  • List the OneTouch Smart Cables in possession, one serial number per cell (The serial number starts with SG and can be found on top of the magnetic connector)
  • Verify and complete the Customer Information.
  • Sign, date, and return the Recall Response Form to Verathon by email to [email protected] to make arrangements for return and replacement of your Core OneTouch Smart Cable.

For Queries on this Device Recall:

Health care professionals and distributors can contact Verathon Inc. through following channels for queries or support for inspection and servicing of the impacted device.

Via Phone: (800) 331-2313, Monday through Friday between 6:00am and 4:00pm (Pacific Time)

Via email: [email protected]

Voluntary MDI (Medical Device Incident) reporting:

Health care professionals and consumers are advised to report the adverse reactions or quality problems experienced with the use of this medical device to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Complete and voluntarily submit the report Online.
• Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178.