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Model Number 174023 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, intra-operatively, the device¿s staple jammed.Patient status and outcome was unknown.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.There were no visual or functional abnormalities observed during the product analysis.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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