(b)(4).Additional information was requested and the following was obtained: for clarification what is the plastic that came loose? did the plastic handle of the device separate and become loose? no, of the tip.Did the white tissue pad on the inactive blade become loose? unknown, we didn¿t receive the device yet to verify it and the customer only stated ¿plastic at the tip of the instrument¿.Did any part of the tissue pad detach from the clamp arm and fall off? unknown, we didn¿t receive the device yet to verify it and the customer only stated ¿plastic at the tip of the instrument¿.The client stated that the plastic of the tip of the instrument came loose during the procedure.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 hand piece and a gen11 and the device did activate during functional testing.The device was disassembled to inspect the internal components 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.The batch record was reviewed and no anomalies were noted during the manufacturing process.
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