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 08/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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, during hernia repair procedure, the stapler jammed.There was no patient injury.
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Manufacturer Narrative
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Section 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 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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