Manufacturer reference number: (b)(4).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.Post market vigilance (pmv) led an evaluation of one device and reload.The event report alleges the product was used in a surgical procedure.There were no visual or functional abnormalities observed during the product analysis.The stapler was loaded with a pmv device loading unit and fired on the test media with acceptable staple formation.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; therefore, a device history record will not be performed.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Based on the evidence available the reported condition was not confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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