Model Number ROB10024 |
Device Problem
Application Program Problem: Parameter Calculation Error (1449)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that during a cori assisted tka surgery the bur was not able to take off the last 1mm of bone (so not able to take off the green).The procedure was completed, with a non-significant delay, using a saw, and the surface was smoothed with a rasp to remove the remainder of green bone shown still present on the screen.The cori robot was still used, and gap block and plane visualizer verified the resection depth was achieved.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that during a cori assisted tka surgery the bur was not able to take off the last 1mm of bone (so not able to take off the green).The procedure was completed, with a non-significant delay, using a saw, and the surface was smoothed with a rasp to remove the remainder of green bone shown still present on the screen.The cori robot was still used, and gap block and plane visualizer verified the resection depth was achieved.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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Section h10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information received, confirmed that the event has already been previously reported under the report reference number 3010266064-2022-00012 (our reference number (b)(4)) and that the device did not malfunction, but the cause of the issue was due to a faulty robotic drill already reported under the report reference number 3010266064-2022-00211 (our reference number (b)(4)).Therefore, it was determined that this case does not meet the threshold for reporting and will be closed as a duplicate.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.Internal complaint reference number: (b)(4).
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Search Alerts/Recalls
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