It was reported that the first clip did not come out to the jaws properly at loading during an operation.The user did test loading several times outside the patient body, then the fourth clip got broken.Therefore, the device was replaced with a new one to complete the operation.No clip fell/remained in the patient.
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(b)(6) the customer returned one unit ae05ml autoend05 ml for investigation.The sample is for tc 1900075487 & tc 1900075488.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 with the rotation tab bent.A double feed was present as two clips were stuck in the jaws.The second clip had a broken hook.The sample appears used as there is biological material present on the device.Reference file anp1900075487 for investigation photos.First, the partially loaded clips in the jaws were manually removed and the trigger cycle was completed.The next clip was out of position in the channel.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 next clip was unable to load properly as the feeder was to the side of the clip.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 9 clips remaining including the two partially loaded clips, indicating that 6 clips were fired by the end user.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.Reference file anp1900075487 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 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.The reported complaint of "clip not loaded properly" was confirmed based upon the sample received.One device was returned with the rotation tab bent.A double feed was present as two clips were stuck in the jaws.The second clip had a broken hook.Upon functional inspection, the next clip was unable to load properly.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.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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It was reported that the first clip did not come out to the jaws properly at loading during an operation.The user did test loading several times outside the patient body, then the fourth clip got broken.Therefore, the device was replaced with a new one to complete the operation.No clip fell/remained in the patient.
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