It was reported that during a laparoscopy-assisted distal gastrectomy, the second or third clip was loaded misaligned and the jaws did not open.The user replaced the device with a new one and the same issue occurred.Therefore, the user stopped using applier and opened a competitor's device to continue the operation.No clips fell in the patient.
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It was reported that during a laparoscopy-assisted distal gastrectomy, the second or third clip was loaded misaligned and the jaws did not open.The user replaced the device with a new one and the same issue occurred.Therefore, the user stopped using applier and opened a competitor's device to continue the operation.No clips fell in the patient.
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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 magnification.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.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 load properly into the jaws of the applier 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.The proximal end of the feeder was also slightly bent.The sample was received with 4 clips remaining in the channel, indicating that 11 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 came out of position.A non-conformance 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 clip stacking prevented the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.The reported complaint of "clips loaded misaligned" was confirmed based upon the sample received.One device was returned with its rotation tab bent and the first clip out of position in the channel.Upon functional inspection, the first clip was unable to load properly into the jaws of the applier as the feeder was to the side of the clip.It was found that the clips were out of position and stacking on one another.The proximal end of the feeder was also slightly bent.The sample was received with 4 clips remaining in the channel, indicating that 11 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 came out of position.A non-conformance has been opened to further investigate this issue.
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