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Catalog Number AE05ML |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history review for the product auto endo5 ml lot #73e1900152 investigation did not show issues related to complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that when the customer tried to load clip, before the clip came out, the clip at the back engages with the clip at the front, it was loading with the clip at the front closed.Customer tried to loading clip several times but same issue.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without mag nification.Visual examination of the returned device revealed that the sample was returned with its rotation tab bent and the first clip out of position in the channel.The returned sample appears used as there is biological material present on the device.Reference file anp1900074444 for investigation photos.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 unable to properly load.The sample was disassembled to inspect the internal components.Upon disassembly, it was found that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 8 clips remaining in the channel indicating that 7 clips were fired by the end user.A capa has been opened to further investigate this issue.Reference file anp1900074444 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 "clip not opened" was confirmed based upon the sample received.The device was returned with its rotation tab bent.The sample was returned with 8 clips remaining in the channel indicating that 7 clips were fired by the end user.Upon functional inspection, it was found that the clips were out of position and stacking on one another which prevented the clips from loading properly into the jaws of the device.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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Event Description
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It was reported that when the customer tried to load clip, before the clip came out, the clip at the back engages with the clip at the front, it was loading with the clip at the front closed.Customer tried to loading clip several times but same issue.
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Search Alerts/Recalls
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