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The investigation results confirm this incident no longer falls within mdr reportability requirements as there was no spacer pad damage identified, no short circuit, and no sealing error displayed while grasping a test medium during testing.Upon inspection of the received complaint device, the spacer pads were inspected for damage and found none.Manual continuity tests were performed and confirmed to be acceptable.The device was then connected to the force triad generator and was recognized; the default number of power bars were displayed.The plug was manually manipulated while plugged into the force triad generator.No issues were observed.The instrument was energized while grasping the test medium until the force triad generator signaled that sealing/coagulation was complete and then automatically stopped energy delivery.The device was able to complete 30 cycles without emitting any buzzing sounds or failing to work, and was able to seal/coagulate/cut as intended.The device plug rfid tag was scanned.The tag reader responded with an "used" which indicates the device was connected to an ft10 generator.Per the ifu, el10107 rev c, lf1837 devices manufactured after september 20, 2021 or later are compatible with ft10 generator software v1.1 ¿ v2.1.0.14, v4.0.1.15 and v4.0.2.25 and force triad generator software v3.6 - v4.0.The complaint device was manufactured on 10/18/2023.The rfid data review was performed in the complaints lab.We cloned the tag.We then checked the uid on a v4.0.2.25 generator(sn t1b47485dx).The uid was recognized as "unknown instrument", refer to figure 11.The rfid uid password was checked for functionality and accuracy and the rfid password was valid.The results of the visual and functional inspection determined that the reported event was confirmed.A review of the dhr for the reported lot/serial number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to - ancillary equipment failure.- device plugged into multiple generators.- ancillary equipment failure.- user tries to connect incompatible cable connector.- not plugged in completely to recognize bar code.- activation button (activation button) not engaged throughout the entire seal cycle the instructions for use (ifu) state: - lf19xx devices are compatible with forcetriad sw v3.6-v4.0, vlft10gen sw v1.1 ¿ v2.1.0.14, v4.0.1.15 and v4.0.2.25 - use caution during surgical cases in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.).For best results, apply the seal to unaffected vasculature.- if the generator provides multiple power settings, use the lowest power needed to achieve the intended effect.- do not use this instrument on vessels in excess of 7 mm in diameter.- if the instrument shaft is visibly bent, discard and replace the instrument.- do not place the vessel and/or tissue in the jaw hinge.Place the vessel and/or tissue in the center of the jaws.- eliminate tension on the tissue while sealing and cutting to ensure proper function.- use caution when grasping, manipulating, sealing, and dividing large tissue bundles.- do not bend instrument shaft.- do not attempt to seal over clips or staples as incomplete seals/damage to the cutting blade will occur.Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.- do not overfill the jaws of the instrument with tissue, as this may reduce device performance.- keep the instrument jaws clean.Build-up of eschar may reduce the seal and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.- the lever must be continually held with the activation button fully depressed until the seal cycle is complete.The lever does not latch into the activation position.- a continuous tone sounds to indicate the activation of rf energy.When the activation cycle is complete, a two-pulsed seal-cycle-complete tone sounds and rf output ceases.- notice ¿ the surgeon may inspect the seal before cutting the vessel or tissue.After inspecting the seal, the surgeon should create a second seal adjacent to the first seal before cutting, as described below.- a tone with multiple pulses indicates that the seal cycle was not completed.Refer to the troubleshooting section for possible causes and corrective actions.Do not cut tissue until you have verified that there is an adequate seal.- to seal adjacent tissue, overlap the edge of the existing seal.The second seal should be distal to the first seal to increase seal margin.- activating energy delivery with a footswitch when the activation button is not fully depressed may result in improper sealing and increase thermal spread to tissue outside the surgical site.Proper pressure is being applied to the tissue when the lever keeps the activation button fully depressed.- energy-based devices, such as esu pencils or ultrasonic scalpels that are associated with thermal spread should not be used to transect seals.- failure to maintain steady pressure on the lever while cutting can result in inadvertent reactivation of energy.- remove any embedded tissue from blade track and jaw hinge area.The reported event will continue to be monitored through post-market surveillance.
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