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U.S. Department of Health and Human Services

Class 2 Device Recall Visionsense

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 Class 2 Device Recall Visionsensesee related information
Date Initiated by FirmOctober 17, 2022
Date PostedNovember 23, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0280-2023
Recall Event ID 91055
510(K)NumberK150018 
Product Classification Confocal optical imaging - Product Code OWN
ProductVS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012
Code Information UDI-DI: 18130400103489 Lot Numbes: 3784719 3784735 3784751 378-4001 378-4002 378-4003 378-4004 378-4006 378-4007 378-4008 378-4009 378-4010 378-4012 378-4013 378-4014 378-4015 378-4016 378-4017 378-4020 378-4021 378-4501 378-4502 378-4503 378-4504 378-4505 378-4506 378-4507 378-4508 378-4510 378-4511 378-4512 378-4513 378-4515 378-4529 378-4531 378-4535 378-4537 3784581 378-4582 378-4583 378-4584 378-4588 378-4589 378-4590 3784592 378-4593 378-4594 3784595 378-4596 3784599 3784601 378-4602 3784603 378-4604 3784605 3784606 3784609 3784610 3784612 3784613 3784614 3784617 378-4618 3784619 3784620 3784621 3784622 3784623 3784624 3784626 3784627 3784628 3784629 3784632 3784633 3784635 3784636 3784637 3784638 3784641 3784644 3784645 3784646 3784648 3784649 3784650 3784651 3784652 3784653 3784654 3784656 378-4657 378-4658 3784659 3784660 3784661 3784662 3784663 3784664 3784665 3784666 3784667 3784669 3784671 3784672 3784674 378-4675 3784676 378-4677 3784679 3784680 3784681 3784682 3784683 3784685 3784686 3784687 3784688 3784689 3784691 3784705 3784706 3784708 3784713 3784715 3784716 3784717 3784718 3784720 3784721 3784723 3784725 3784726 3784727 3784728 378-4729 3784731 3784732 3784733 3784734 3784736 3784738 378-4739 378-4740 378-4742 3784743 3784744 378-4745 3784746 3784752 3784753 3784755 3784757 3784758 3784759 3784760 3784761 3784762 3784763 3784764 3784765 3784766 378-4767 378-4768 378-4769 3784775 3784776 3784777 3784779 3784780 3784781 3784789 3784790 3784791 3784792 3784793 3784798 3784799 3784801 378-4805 378-4806 3784809 3784811 3784812 3784813 3784819 3784821 3784822 3784824 3784825 3784826 3784827 3784828 378-4829 3784834 3784837 3784838 3784839 3784841 378-4858 3784863 3784864 3784865 3784867 3784868
Recalling Firm/
Manufacturer		 Visionsense, Ltd.
20, Ha-Magshimim
Petakh Tikva Israel
For Additional Information ContactMedtronic 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 2		Under Investigation by firm
ActionMedtronic 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 Commerce205 units: 94 units OUS; 111 units US
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWN
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