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Catalog Number LX107 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Only event date known: 2019.Device analysis: 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.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 during an unknown procedure, the clip applier is not closing properly.It is not meeting at the ends, at the tips.Unknown how the case was completed.There were no patient consequences reported.There is no further information available about the event.
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Search Alerts/Recalls
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