Catalog Number 5507-001 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding event, product, or patient details has been requested.No additional information is available at this time.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
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Event Description
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Healthcare professional reported a xen®45 gts event described as the slider got stuck and implant broke during implantation in left eye.Surgery was completed with second xen®45 gts device.No eye injury noted.
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Event Description
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Healthcare professional reported a xen®45 gts event described as the slider got stuck and implant broke during implantation in left eye.Surgery was completed with second xen®45 gts device.No eye injury noted.
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Manufacturer Narrative
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Device analysis: the needle cover was attached.The retention plug and cam lock were each detached and not returned.The xen gel stent was not returned.A visual evaluation of the xen injector was performed.The slider of the injector was not in the start position and was significantly advanced, the needle was fully retracted, and the bevel was in the center position.The slider knob was able to slide the full distance of the travel length in each of the three bevel selector positions.The functional testing showed that the pusher rod which pushes the gel stent out of the needle performed correctly, and the needle moved in tandem with the slider knob.The needle was fully extended as the slider knob was at the start position, and the needle retracted properly as the slider knob was advanced to the end of the travel distance.Since the slider knob was able to slide the full distance of the travel length of each of the three bevel selector positions and since resistance was not observed, the expected condition was met.The reported complaint of blocked slider is not confirmed since the slider knob was able to slide the full distance of the travel length of each of the three bevel selector positions and since resistance was not observed during functional testing.
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Search Alerts/Recalls
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