Model Number 6000-011-000 |
Device Problems
Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2022 |
Event Type
malfunction
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Event Description
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Per the customer, the pointer was bent during the case which could lead to an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Event Description
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Per the customer, the pointer was bent during the case which could lead to an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
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Manufacturer Narrative
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Update: d9, h3, h6 device evaluation: follow-up report submitted to document the device was not available for evaluation.No product return per the customer.
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Search Alerts/Recalls
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