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Model Number 030404 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/05/2019 |
Event Type
malfunction
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Event Description
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As the operating room staff were setting up for a bariatric case, they tried opening the lsi solutions tk tiknot (ref 030404) device packaging but it wouldn't open properly.The packaging wouldn't peel open as it normally would, but rather the paper cover was peeling in half.Since the staff couldn't guarantee the sterility of the contents of the package/device, they couldn't use the device and had to open a second device.
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Event Description
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As the or staff were setting up for a bariatric case, they tried opening the lsi solutions tk tiknot (ref: (b)(4) device packaging but it wouldn't open properly.The packaging wouldn't peel open as it normally would, but rather the paper cover was peeling in half.Since the staff couldn't guarantee the sterility of the contents of the package/device, they couldn't use the device and had to open a second device.
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Search Alerts/Recalls
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