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Catalog Number LX107 |
Device Problems
Crack (1135); Failure to Align (2522); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation summary: the analysis results confirmed that the lx107 device was returned nonfunctional as the jaws were misaligned; therefore, the clips could not be loaded into the jaws.No damage on the handle coating was noted at any time during the analysis of the device.It is possible that the damaged was due to an improper handling of the device.Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use." the batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment. the certificate records are accessible through external manufacturing. .
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Event Description
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It was reported that in sterile processing, it was found that the tips are bent and are not aligning properly, and the handles are cracking.There was no patient involvement.
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Search Alerts/Recalls
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