VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

FDA device recall Z-0282-2023 · posted 2022-11-23 · Open, Classified

Recall details

Recalling firm

Visionsense, Ltd.

Reason for recall

Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.

Action taken

Medtronic issued Urgent Medical Device Correction Letter on 17-OCTOBER-2022 to US consignees via UPS 2-day delivery. For outside U.S. countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and action to take: 1.Prior to use, visually check the Beam-Combiner and MMS optical fiber cable for signs of being pinched, kinkedor damaged. Avoid folding the cables and handle with care to prevent damage. 2.After the white balance has been performed as per IFU guidance, test the EleVision IR system at the beginningof the surgical procedure as follows: a)Turn on the laser. b)For the laparoscopic configuration of the EleVision IR system, point the distal end of the endoscopetowards a bright surface, keeping the scope approximately 3 cm from the target. This prevents thewhite light from scattering. For the open configuration of the EleVision IR system, position the distalface of the MMS approximately 30 cm from any object. If you see a message on the screen indicatingthat the device is too close to tissue, move the device further away from the object until this messagedisappears. c)After two (2) seconds, the monitor screen should show a message indicating that the laser is on, ablinking red dot, and a running clock. If all these indications are seen properly on the monitor screen,turn off the laser after five (5) seconds. If the screen does not show an indication that the laser is on, a blinking red dot, and a running clock, the laser is not functioning properly and the EleVision IR system should not be used in the surgical procedure. If any pinching, kinking, or damage of the optical fiber cable is noted, or if the system does not work properly during the above-described laser test, do not use the system. Please report a complaint and arrange for servicing of the Beam Combiner and / or MMS device by contacting Medtronic at 1-800-255-6774 or rs.serviceexperience@medtronic.com. Additional actions: "Immediately notify

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OWN

Quantity affected

204 units: 93 units OUS ; 111 units US

Distribution

US Nationwide distribution.

Date initiated

2022-10-17

Date posted

2022-11-23

Location

Tikva, Israel

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