Correction to g3 of the initial medwatch.The aware date should be 11-feb-2022.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The subject device was returned and evaluated where it was found that the clip was attached to the device when it arrived for investigation, no buckling was observed in the insertion portion, the clip opened/closed when the slider was moved, the limiter in the control section of the clipping device was not broken off, when the slider was forcefully pulled, the limiter placed inside the control section broke with a sound.Before providing the root cause, the following information regarding the steps to release the clip will be provided.This information helps to understand the content of the root cause of the reported event.1.When pulling the slider, the operation wire, the hook and the clip arms are linked together, and they are pulled together in the proximal direction.This motion closes the clip arms.2.When the slider is further pulled after closing the clip arms, the protrusions of the clip arms will move to the outside of the clip pipe.Once it happens, the small protrusions of the clip arms will be fix to the edge of the clip pipe.As a result, the clip cannot be opened or closed.The clip can be opened and closed by operating the slider to a position where the small protrusions of the clip arms do not come out of the clip pipe.3.When the slider is further pulled after the clip does not open or close, the limiter located in the slider breaks with the noise of snapping.(the user recognizes that clipping was completed by hearing the sound.) 4.After the limiter breaks, the joint between the hook and the clip arms will be unhooked by moving the slider forward.As a result, the clip will be released from the product.5.Based on the product structure, it is possible that the slider was not fully pulled until the limiter placed in the control section broke.Therefore, the clip could not be released from the product.However, the exact cause could not be determined.The following is including in the device instructions for use (ifu) and may help prevent and/or detect the reported issue: "operation of this instrument is based on the assumption that open surgery is possible as an emergency measure if the clip cannot be detached from the instrument or if any other unexpected circumstance takes place.In this case, refer to chapter 14, ¿emergency treatment¿." "do not withdraw the instrument forcibly or change the angulation of the endoscope when the clip is grasping the tissue and is not released.Doing so may tear tissue inside the body cavity, resulting in patient injury, such as perforation, bleeding, or mucous membrane damage." "do not angulate the bending section of the endoscope or withdraw the instrument from the endoscope while the clip is grasping the tissue before being released.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage." "do not try to forcibly withdraw the instrument from the endoscope if the clip cannot be detached from the instrument.Forcibly withdrawing the instrument could cause patient injury such as perforation, bleeding, or mucous membrane damage." "should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of ¿withdrawing the instrument from the endoscope¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result." olympus will continue to monitor field performance for this device.
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