Catalog Number 5100060001 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/26/2013 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure, the perforator failed to perforate a hole.It was further reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.
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Manufacturer Narrative
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The device was made available for return.The quality investigation is complete.
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Event Description
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It was reported that during a procedure the perforator failed to perforate a hole.It was further reported that there was no adverse consequences as a result of this event and the procedure was completed successfully.
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Manufacturer Narrative
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The device is available for return.A follow up report will be filed once the quality investigation is complete.Awaiting device return.
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Search Alerts/Recalls
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