Catalog Number A105400000000 |
Device Problems
Detachment of Device or Device Component (2907); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received with a similar device where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it is reported that a x-smart iq basic starter kit won't hold files.No injury occurred.
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Manufacturer Narrative
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Investigation results: received: 1x x-smart iq contra-angle a105100000000 sn: (b)(6).X-smart iq ca head housing sav bad maintenance (user) rusty.Improper / inadequate cleaning, maintenance replaced 1x iq contra-angle a105100000000 40940.
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Search Alerts/Recalls
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