Model Number 81-81041 |
Device Problems
Image Display Error/Artifact (1304); Image Orientation Incorrect (1305)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/23/2019 |
Event Type
malfunction
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Event Description
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It was reported that during a surgery, it was observed that the orientation of the instrument was wrong in the ap image.The possible harm associated with inaccuracy during a procedure is revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
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Event Description
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It was reported that during a surgery, it was observed that the orientation of the instrument was wrong in the ap image.The possible harm associated with inaccuracy during a procedure is revision surgery.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
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Manufacturer Narrative
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Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.
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Search Alerts/Recalls
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