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 05/03/2023 |
Event Type
malfunction
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Event Description
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Per the customer, the tip was bent during a case, which could possibly lead to an incorrect measurement.The procedure was completed successfully with the same device without a surgical delay; no medical intervention or adverse consequences were reported.
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Event Description
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Per the customer, the tip was bent during a case, which could possibly lead to an incorrect measurement.The procedure was completed successfully with the same device without a surgical delay; no medical intervention or adverse consequences were reported.
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Manufacturer Narrative
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Correction: follow-up report submitted to document the device was not available for evaluation.H3 other text : device not returned.
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Search Alerts/Recalls
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