(b)(4).A device history record review could not be performed as no lot number was provided by the customer.This sample was inspected with a r & d engineer.Functional inspection was performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, no ratchet sound could be heard indicating that the internal ratchet ears are broken.The first clip was able to properly load into the jaws of the device and close.This was repeated with the same result for the remaining clips.The sample was received with 5 clips remaining in the channel indicating that 10 clips were fired by the end user.The sample was disassembled to inspect the internal components.Upon disassembly, no further damages were found.Although the remaining clips were all able to fire properly, the broken ratchet ears could prevent the clips from properly loading into the jaws.Based on the condition of the returned sample, it was determined that the broken ratchet ears were caused by operational context.Reference file (b)(4) for investigation photos.Other remarks: a functional leak test was performed on the returned sample per mrq 000017 section 7.5; rev.7.The returned epidural catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was closed.The components were confirmed to be secured by tugging gently.The snaplock adapter was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.No leaks were detected and the components remained secured.A functional spo test was then performed per mrq 000017 section 7.7; rev 7.The proximal end of the epidural catheter was re-inserted into the snaplock adapter until it bottomed out and the snaplock adapter was locked.The components were confirmed to be secured by tugging gently on the catheter.The components were then left to sit for 72 hours in the locked position.After 72 hours , the snaplock adapter was confirmed to have remained securely locked with the catheter inserted.No corrective action needed at this time since no functional issues were found with the returned snaplock adapter.The reported complaint of the snaplock adapter disconnecting from the catheter could not be confirmed through functional testing of the returned snaplock adapter.The snaplock adapter was secured to the epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.There was no problem found with the returned snaplock adapter.
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