(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 the rotation tab bent and the first clip out of position in the channel.The sample appears used as there is biological material present on the device.Functional inspection was 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 clip was unable to load on the first attempt as it became stuck in the bent rotation tab.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.The sample was received with 4 clips remaining in the channel, indicating that 11 clips were fired by the end user.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A capa 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 do not come out-jamming" was confirmed based upon the sample received.The sample was returned with the rotation tab bent and the first clip out of position in the channel.Upon functional inspection, the clip was unable to load on the first attempt as it became stuck in the bent rotation tab.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another.The proximal end of the feeder was slightly bent due to the clip stacking.The clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A capa has been opened to further investigate this issue.
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