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WHAT IS THIS?
A Urgent Field Safety Notice is communication sent by a manufacturer to users or customers in relation to a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
EVENT
| Type of Event | Urgent Field Safety Notice |
|---|---|
| Notice Reference | 1170852 |
| Notice Qty | All unexpired lots manufactured from November 1, 2022 to present |
| Notice Date | March 2025 |
| Notice Link | Getinge Vasoview Hemopro 2 - Bent Heater Wire |
| Notes/Details | None |
| Reason | Company received complaints for the following two (2) failure modes experienced during use: 1. A bent or detached heater wire 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
DEVICE
| Manufacturer | Getinge |
|---|---|
| Model Names | Vasoview Hemopro 2 Endoscopic Vessel Harvesting System |
| Model Numbers | VH-4000 and VH-4001 |
| Part/Item/Catalog/ REF/Product Number | - |
| Device Description | The Vasoview Hemopro 2 EVH System is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. The device is indicated for cutting tissue and controlling bleeding through coagulation for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. |
| Serial Number(s) | N/A |
| Lot #/Exp Date(s) | All unexpired lots with manufacturing dates from November 1, 2022 to Present |
CUSTOMER/PATIENT ACTIONS
1. Review the IFU information provided in Appendix A, specifically note the following warnings to minimize over delivery of energy:
• When inserting or retracting the Harvesting Tool through the Harvesting Cannula,
close the Jaws and ensure the Jaw tips are oriented upwards (concave side up) to
prevent damage to the Jaws.”
• “Application of energy without tissue between the Jaws of the Harvesting Tool should be kept to minimum in order to maximize Harvesting Tool performance.”
• “When separation of the branch tissue is noticed, open the Jaws and stop application of energy by pushing the Activation Toggle into the forward most position and retract the Harvesting Tool slightly.”
“NOTE: Once material has been transected,stop application of energy.”
2. Consider the following to mitigate the risks:
• Inspect the device prior to use for any signs of damage including silicone peeling away from the jaws.
• Check the outer surface of the device for rough surfaces, sharp edges, or unusual protrusions that may be a hazard.
• Monitor the device during use for silicone peeling away from the jaws.
• Inspect the device after use for missing or damaged parts.
• If, at any time of use, the user notices missing or damaged parts or peeling of silicone, device use should be terminated, and any fragmented components should be located and removed from the patient.
• Monitor patients for complications if you suspect fragment(s) of the device may have been retained. Future complications could include delayed onset of pain, infection, and/or localized allergic/adverse reaction.
3. Getinge has created a training video, accessible via the QR code or link below, to guide users on the proper use of the device and reinforce essential precautions. Use the QR code to access the training .
• Scanning the barcode will direct you to the landing page, where you’ll find instructions on the next steps to access the 7-minute training video.
CONTACT INFORMATION
If you have any questions regarding this notification, please contact your MCV/Getinge sales representative.
PLEASE EMAIL OR FAX THIS ACKNOWLEDGEMENT TO:
hemopro-peeling-detached-silicone2024.act@getinge.com
