Catalog Number 0250070520 |
Device Problems
Material Fragmentation (1261); Particulates (1451); Output Problem (3005)
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Patient Problems
Deposits (1809); Insufficient Information (4580)
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Event Date 03/24/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the device released a sizable white piece of plastic while irrigating.It could not be confirmed if any of the white plastic entered the patient and if the piece was retrieved.
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Event Description
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It was reported that the device released a sizable white piece of plastic while irrigating.It could not be confirmed if any of the white plastic entered the patient and if the piece was retrieved.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: they had a strykeflow 2 (250-070-520) that released a sizable white piece of plastic while irrigating the probable root causes could be the material left behind during the manufacturing process, or from the fluid bag.The failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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