Class 2 Device Recall

• Date Initiated by Firm: October 17, 2022
• Date Posted: November 23, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0282-2023
• Recall Event ID: 91055
• 510(K)Number: K150018
• Product Classification: Confocal optical imaging - Product Code OWN
• Product: VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
• Code Information: UDI-DI: 18130400103625 Lot Numbers: Serial Number/Lot Number 3611111 3611161 3611191 361-0012 361-0901 361-0902 361-0903 361-0904 361-0906 361-0907 361-0908 361-0909 361-0910 361-0911 361-0913 361-0914 361-0915 361-0916 361-0917 361-0918 361-0919 361-0921 361-0922 361-0923 361-0924 361-0926 361-0929 361-0931 361-0932 361-0933 361-0937 361-0938 361-0940 361-0941 3610942 361-0943 361-0944 361-0945 3610946 3610947 3610949 3610950 3610951 3610952 3610953 361-0955 3610956 3610957 3610958 3610961 3610963 3610964 3610965 361-0966 3610968 361-0970 3610971 3610972 3610973 3610974 3610975 3610977 3610978 3610979 3610996 3610998 3610999 3611000 3611004 3611006 3611007 3611008 3611009 3611011 3611012 3611014 3611015 3611016 3611019 3611025 3611027 3611029 3611031 3611033 3611034 3611035 3611036 3611039 3611041 3611042 3611044 3611046 3611048 3611049 3611052 3611053 3611055 3611056 3611057 3611058 3611059 3611060 361-1061 3611062 3611063 3611065 361-1067 3611068 3611070 3611071 3611073 3611075 3611077 3611078 3611079 3611080 3611082 3611083 3611084 3611085 3611086 3611087 3611088 3611092 3611096 3611097 3611099 3611100 3611101 3611102 361-1103 3611104 3611106 3611108 3611109 3611110 3611112 3611113 3611114 3611116 3611117 3611118 3611119 3611120 3611121 361-1122 3611123 3611124 3611125 3611126 3611128 3611129 3611130 3611131 361-1132 3611133 3611134 3611135 3611136 3611138 3611139 3611140 361-1144 3611146 361-1148 3611149 3611152 3611153 3611154 3611156 3611157 3611158 3611159 3611162 3611167 361-1168 3611170 3611171 3611172 3611173 3611174 3611175 3611176 3611177 3611178 3611180 3611181 3611182 3611188 3611189 3611190 3611194 3611195 3611196 3611197 3611199 3611200 3611201 3611218 3611219 3611223 3611224 3611225 361-1013
• Recalling Firm/ Manufacturer: Visionsense, Ltd.; 20, Ha-Magshimim; Petakh Tikva Israel
• For Additional Information Contact: Medtronic Customer Service ; 800-962-9888
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 204 units: 93 units OUS ; 111 units US
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWN