Model Number 5513-001 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2022 |
Event Type
malfunction
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Event Description
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Healthcare professional reported a xen®45 gts event described as "safety tab hard to remove causing product not to slide smoothly.Tab very thick, injector got stuck." device did not make patient contact.Surgery was completed with second xen®45 gts device.No eye injury noted.
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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 completed.No deviations or non-conformances noted.
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Event Description
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Healthcare professional reported a xen®45 gts event described as "safety tab hard to remove causing product not to slide smoothly.Tab very thick, injector got stuck." device did not make patient contact.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: one xen 45 gts enhanced injector was received.The molded tray was returned.The xen glaucoma treatment system (gts) unit box was returned.The injector was received with a black rubber needle guard attached to the injector.The needle cover, retention plug, and cam lock were not returned.The slider knob was in the end position and the bevel selector in the center position.The gel stent was not returned.A visual inspection of the device was performed.No atypical observations were made nor damage observed.A functional test was performed.The slider knob was able to slide the full distance of the travel length in each of the three bevel selector positions, and audible clicks were heard during the process.The functional testing showed that the pusher rod which pushes the gel stent out of the needle performed correctly and the needle retracted properly as the slider knob was advanced to the end of the travel distance.Since all of the expected conditions were met, no further evaluation is required.The reported complaint conditions were not confirmed since no damage was observed and the injector met all of the expected conditions when functional testing was performed.
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Search Alerts/Recalls
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