Catalog Number 6215000000 |
Device Problems
Disassembly (1168); Device Disinfection Or Sterilization Issue (2909)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/26/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
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Event Description
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It was reported that during a surgical procedure at the user facility the device fell apart, potentially exposing the surgical site to non-sterile internal components.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.
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Manufacturer Narrative
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As this is not a repairable device, it was not returned to the customer.
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Event Description
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It was reported that during a surgical procedure at the user facility the device fell apart, potentially exposing the surgical site to non-sterile internal components.The procedure was completed successfully.No delay, no medical intervention, and no adverse consequences were reported with this event.
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Search Alerts/Recalls
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