Catalog Number LX107 |
Device Problems
Failure to Align (2522); Device Fell (4014)
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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 year known: 2019.Possible serial numbers: (b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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Event Description
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It was reported that the jaws of the clip appliers are misaligned, resulting in the clips falling out of the jaws of the instrument during use or not locking on tissue during use.No patient involvement was reported.
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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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