(b)(4).Batch # n9240u.Investigation summary: the analysis results found that the device was received with the tissue pad detached and not returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test handpiece and tested on a gen11.The device was functional when the max or min hand activation buttons were depressed.The instrument was disassembled to inspect the hand button assembly for evidence associated with activation issues and no anomalies were found.Based on the condition of the tissue pad, a probable cause for this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in removal of the pad during use.It could not be determined what may have caused the reported incident of the scalpel could not be activated by the hand activation during the procedure.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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