(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its trigger partially engaged and with the rotation tab bent.A clip was partially loaded incorrectly in the jaws of the device.The returned sample appears used as there is biological material present on the device.First, the partially loaded clip was manually removed , and the trigger cycle was completed.Functional inspection was then performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The next clip was unable to load properly as the feeder was to the side of the clip.On the next attempt, the indicator clip fired.The sample was disassembled to inspect the internal components.No further damages were observed.The sample was received with 2 clips remaining, including the partially loaded clip, indicating that 13 clips were fired by the end user.The bent rotation tab and the clip misload where the feeder was to the side of the clip are indications that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." the reported complaint of "clip not loaded properly" was confirmed based upon the sample received.One sample was returned with its trigger partially engaged and with the rotation tab bent.A clip was partially loaded incorrectly in the jaws of the device.Upon functional inspection, the next clip was unable to load properly as the feeder was to the side of the clip.The bent rotation tab and the clip misload where the feeder was to the side of the clip are indications that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.
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