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Catalog Number AE05ML |
Device Problems
Failure to Advance (2524); Device Fell (4014)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/08/2019 |
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 #73l1800543 investigation did not show issues related to the 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 during laparoscopic cholecystectomy, the first clip got stuck and did not come to the jaws.After firing the applier several times outside the patient body, the md tried to load a clip in the patient again, however, the fourth clip fell at loading.The fallen clip was retrieved; no clip remained in the patient and no injury to the patient occurred.
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.The sample is for tc (b)(6) and tc (b)(6).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 the rotation tab bent.A clip with a broken hook was partially loaded incorrectly.The 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 first clip was unable to load properly into the jaws.The next clip had a broken hook and was protruding from the channel.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 proximal end of the feeder was slightly bent due to the clip stacking.The sample was received with 8 clips remaining including the partially loaded clip, indicating that 7 clips were fired by the end user.Two of the returned clips were broken at the hook.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, as observed with this sample.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.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 stuck in applier" was confirmed based upon the sample received.One device was returned with the rotation tab bent.The bent rotation tab can cause the clips to become stuck in it.A clip with a broken hook was partially loaded incorrectly.Upon functional inspection, the first clip was unable to load properly into the jaws.The next clip had a broken hook and was protruding from the channel.The sample was disassembled , and 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.Two of the returned clips were broken at the hook.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, as observed with this sample.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 during laparoscopic cholecystectomy, the first clip got stuck and did not come to the jaws.After firing the applier several times outside the patient body, the md tried to load a clip in the patient again, however, the fourth clip fell at loading.The fallen clip was retrieved; no clip remained in the patient and no injury to the patient occurred.
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Manufacturer Narrative
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(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.
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Search Alerts/Recalls
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