It was reported that during lower anterior resection, a clip was loaded misaligned.The user took the device out of the patient's body and tested loading several times, which resulted in failure.Therefore, the device was replaced with ligamax.No clip fell in the patient.
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(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 trigger partially engaged and with the rotation tab bent.A clip was partially loaded incorrectly as the feeder was to the side of the clip.The returned sample appears used as there is biological material present on the device.The sample was also returned with four loose clips, where two were open and two were closed.The clips appear used as there is biological material present on the clips.First, the partially loaded clip was manually removed , and the trigger cycle was completed.At this time, it was observed that the next clip was out of position in the channel.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 next clip was unable to load properly as the feeder was to the side of the clip.Another attempt was made , and the following clip was also unable to load properly.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 clip stacking could prevent the clips from properly loading into the jaws.The sample was received with 12 clips remaining, including the partially loaded clip and the four loose clips, indicating that 3 clips were fired by the end user.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking 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 "clips loaded misaligned" was confirmed based upon the sample received.One device was returned with its trigger partially engaged and with the rotation tab bent.A clip was partially loaded incorrectly as the feeder was to the side of the clip.The sample was also returned with four loose clips, where two were open and two were closed.The trigger cycle was completed , and it was observed that the next clip was out of position in the channel.Upon functional inspection, the next clip was unable to load properly as the feeder was to the side of the clip.Another attempt was made , and the following clip was also unable to load properly.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 12 clips remaining, including the partially loaded clip and the four loose clips, indicating that 3 clips were fired by the end user.It could not be determined exactly how or when the clips came out of position.A nonconformance has been opened to further investigate the clip stacking issue.
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It was reported that during lower anterior resection, a clip was loaded misaligned.The user took the device out of the patient's body and tested loading several times, which resulted in failure.Therefore, the device was replaced with ligamax.No clip fell in the patient.
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