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 the trigger partially engaged and the rotation tab bent.The sample appears used as there is biological material present on the device.Reference file anp1900073785 for investigation photos.First, the trigger cycle was completed.It was observed that the first 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 was heard indicating that the internal ratchet ears are intact.The first clip was unable to load properly as the feeder was to the side of the clip.The sample was disassembled in order to inspect the internal components.It was found that the clips were out of position and stacking on one another in the channel.Both jaws also had a uniform bend to them.The pivot holes in the channel for the jaws were deformed.The sample was received with (b)(4)
clips remaining in the channel indicating that the end user fired 5 clips.The damage to the jaws prevented the clips from loading properly.It is unlikely that the clip stacking caused the observed damages to the jaws.The uniform bend to the jaws indicates that there was a significant side load applied to the jaws that caused them to bend.If a clip misloads and is not manually cleared prior to loading another clip, the clips can be held up in the loading sequence and stack on one another in the channel.Therefore, based upon the damage observed, unintentional user error caused or contributed to this event.Reference file anp1900073785 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."
a corrective action is not required at this time as the condition of the sample received indicates that unintentional user error caused or contributed to this event.The reported complaint of "clip not opening" was confirmed based upon the sample received.The sample was returned with the rotation tab bent.Upon functional inspection, the first clip was unable to load properly.It was found that the clips were out of position and stacking on one another in the channel.Both jaws also had a uniform bend to them.The pivot holes in the channel for the jaws were deformed.The observed damages to the jaws prevented the clips from loading properly.The uniform bend to the jaws indicates that there was a significant side load applied to the jaws that caused them to bend.At the time of manufacturing assembly, the autoend05 is 100% inspected for proper clip loading and closure.It is unlikely that this type of damage was present at the time of manufacturing.A device history record review was performed on the device with no evidence to suggest a manufacturing related defect.Therefore, based upon the observed damage, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.
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