Model Number 12-0540250 |
Device Problems
Difficult to Remove (1528); Failure to Disconnect (2541)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Additional information and the return of the reported device has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The appropriate device details have been provided and the relevant device manufacturing records will be requested and reviewed.
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Event Description
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Revival proximal body trial would not disengage correctly from the distal component.Excessive force was required to remove the trial.
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Manufacturer Narrative
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Per - (b)(4) final report; functional testings were performed which did not reveal any anomaly: no excessive force was necessary to remove the device.The origin of the complaint may be related to a misuse.Based on this, corin now considers this case closed.
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Event Description
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Revival proximal body trial would not disengage correctly from the distal component.Excessive force was required to remove the trial.
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Search Alerts/Recalls
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