(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 tip of the rotation tab broken off.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 first clip was able to load properly and was successfully applied to over-stressed surgical tubing.The indicator clip was in the next position of the channel indicating that no clips were remaining.The indicator clip was fired.The sample was disassembled to inspect the internal components.No further damages were observed.The sample was received with 1 clip remaining in the channel, indicating that 14 clips were fired by the end user.Although the lone clip remaining fired properly, the bent rotation tab is an indication that the clips were out of position and stacking on one another in the channel.The clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.Capa has been opened to further investigate this issue.Other remarks: the device history review for the product auto endo5 ml lot# 73d1900709 was manufactured on 04/30/2019 a total of (b)(4) pieces.Lot was released on 05/08/2019.Dhr investigation did not show issues related to the complaint.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 clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips became out of position.The reported complaint of unit misfired was confirmed based upon the sample received.One sample was returned with the rotation tab bent and the tip of the rotation tab broken off.Upon functional inspection, the lone clip fired properly.However, the bent rotation tab is an indication 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.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.Teleflex will continue to monitor and trend related events.
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