A reprocessed LigaSure™ vessel-sealing device may look the part, but a study published in Surgical Endoscopy shows they may have visible contamination on them.1,†
WATCH THE VIDEOThere are significant differences between original equipment manufacturer (OEM) LigaSure™ devices and third-party reprocessed LigaSure™ devices. Learn how to quickly identify inauthenticity — because if it’s not LigaSure™ technology from Medtronic, it’s not LigaSure™ technology.
READ THE STUDY168 DEVICES DISASSEMBLED AND TESTED:
84 OEM LigaSure™ vessel-sealing devices
84 Stryker™* vessel-sealing devices
Make the authentic choice — use the original vessel-sealing device. Only OEM LigaSure™ devices are backed by Medtronic.
If there’s a logo other than Covidien™ or Valleylab™ –– it’s not from Medtronic.
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*Medtronic does not manufacture, distribute, warrant, or indemnify reprocessed LigaSure™ vessel-sealing devices. Check the packaging, the product, and the plug to make sure there’s only the Covidien™ or Valleylab™ logo.
† Contamination was found following disassembly of the devices and jaws. The study found that 52% of reprocessed devices studied had visible contamination. The remaining 48% did not have contamination that was visible to the naked eye.
‡ Hemoglobin detection was presumptive based on unexpected luminescence
§ The combination of failed tests included visual inspection, optical and scanning electron microscopy, hemoglobin detection, and sterility testing.
Ω Sterility assurance level of 10-6 accepted by the FDA as laid out in the Association for the Advancement of Medical Instrumentation (AAMI) standards ST67 and TIR 12 for devices contacting normally sterile tissue
†† Nano-coating is available on select LigaSure™ devices. Refer to the OEM Instructions for Use. Standard methods will degrade the nonstick coating. Devices without nano-coating may have more sticking, eschar buildup, and cleanings.
‡‡ Please consult the OEM LigaSure™ device Instructions for Use.
1. Chivukula, S.R., Lammers, S. & Wagner, J. Assessing organic material on single-use vessel sealing devices: a comparative study of reprocessed and new LigaSure™ devices. Surg Endosc (2020). https://doi.org/10.1007/s00464-020-07969-8.
2. Based on internal test report #RE00065374 Rev A, LF18XX product claims report for reprocessed jaws. Sept. 22 and Sept. 29, 2016.
3. Based on internal test report #RE00065124, Lig-40 LF4418 product claims report for reprocessed jaws: benchtop testing conducted with reprocessed device jaws using porcine tissue, porcine blood, and average (lb) tissue sticking force. Oct. 4–7, 2016.
4. Based on internal report #RE00045785, LF19XX Waiver of Sticking Testing Post-reprocessing. Jan. 19, 2017.
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