Model Number 8000-020-002 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2022 |
Event Type
malfunction
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Event Description
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Per the customer, the device was inaccurate by 5mm during a surgical procedure.Additional information has been requested from the user facility.
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Manufacturer Narrative
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The device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : not all log files were submitted by the customer for evaluation.
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Event Description
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Per the customer, the device was inaccurate by 5mm during a surgical procedure.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
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Search Alerts/Recalls
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