Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample is for tc 1900075116 & tc 1900075117.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 with blue adhesive residue on the trigger.The sample appears used as there is biological material present on the device.Reference file anp1900075117 for investigation photos.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 first clip became stuck in the bent rotation tab.The next clip was protruding from the channel and the following clip was out of position.The sample was disassembled to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.The sample was received with 11 clips remaining in the channel, indicating that 4 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 became out of position.A capa has been opened to further investigate this issue.Reference file anp1900075117 for investigation photos.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 "clips broken out of applier" was confirmed based upon the sample received.One device was returned with the rotation tab bent.Upon functional inspection, the first clip became stuck in the bent rotation tab.The sample was disassembled , and it was found that the clips were out of position and stacking on one another.The clip stacking prevented the clips from loading properly into the jaws.The clip stacking can also cause the clips to break in the channel.Although the reported complaint issue was confirmed based on functional testing, it could not be determined exactly how or when the clips became out of position.A capa has been opened to further investigate this issue.
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