(b)(4).Post market vigilance (pmv) led, an evaluation of two skin staplers opened by the account.The visual inspection of the device noted the instruments were partially applied.The tab at the proximal end of the instruments was broken; therefore no functional testing was performed.The observed conditions were confirmed to be caused by the incorrect removal of a piece of the paper wrap that covers the stapler handle prior to use.However, it is noted that the instructions for use do not establish guidelines to remove the unit from the package.If the device handle is actuated with the packaging still attached to the device, the tab will break causing the device to malfunction.This can cause staple jamming, unsuccessful firing, staple malformation and other similar outcomes.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
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