Model Number 1873 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/29/2019 |
Event Type
malfunction
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Event Description
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It was reported that the sterile bag was not completely sealed.A 7f guidezilla ii was selected for use.During preparation, it was observed that the bottom part of the sterile bag was not sealed.The procedure was completed with a different device.No patient complications were reported.
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Event Description
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It was reported that the sterile bag was not completely sealed.A 7f guidezilla ii was selected for use.During preparation, it was observed that the bottom part of the sterile bag was not sealed.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The shelf box and product pouch were visually inspected.Visual inspection revealed that the seal on the shelf box is open.The pouch was taken out and visually inspected and the bottom of the pouch is not sealed.Inspection of the remainder of the device presented no damage or irregularities.
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Search Alerts/Recalls
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