Catalog Number 0450000000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the joint was distending.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: distendening the joint.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: user setup.Improper joint level.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the joint was distending.
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Search Alerts/Recalls
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