Catalog Number 219999 |
Device Problems
Output Problem (3005); No Visual Prompts/Feedback (4021)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Mako arm was out of focus.Update: case type: tka 1.0.
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Manufacturer Narrative
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An event regarding arm haptic issue involving a mako robotic arm was reported.The event was not confirmed because the product was not available for inspection.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: a product history review is not required, as no manufacturing specific issue has been alleged.At stryker joint replacement all devices/product are manufactured through validated equipment and inspected by trained representatives through stryker¿s quality management system.-complaint history review: a complaint history review and trend detection is not required as this is a pm.Monitoring will be continued under the current quarterly trend review.Conclusions: no patient was involved and no actual or potential patient harm existed for the alleged event.The alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Event Description
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Mako arm was out of focus.Update: case type: tka 1.0.
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Search Alerts/Recalls
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