Catalog Number CAT02438 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.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 cannula cracked during the procedure.
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Event Description
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It was reported that the cannula cracked during the procedure.
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Manufacturer Narrative
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Alleged failure: the rep emailed to c360 on 5-21-2019 but it never was seen due to a glitch in our system, angel garza is aware of the issue.Seam where polymer tip meets metal shaft of flowport cannula broke.Caused obturator to become stuck and unable to be removed.Surgeon says this is second time this has occurred at same spot when using flowport.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause could be excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Search Alerts/Recalls
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