Catalog Number HH9006 |
Device Problems
Delivered as Unsterile Product (1421); Structural Problem (2506)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 sterile drape was not sealed completely.No adverse consequences were reported.
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Manufacturer Narrative
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Alleged failure: "drape isn't sealed completely" probable root cause/s: reported issue is likely due to a failure of the bottom pouch seal.This seal is applied in-house by drape oem premier guard and oem investigation is ongoing to determine root cause.The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the sterile drape was not sealed completely.No adverse consequences were reported.
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Search Alerts/Recalls
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