(b)(4).Batch # r94l7a.Investigation summary: the device was returned with no apparent damage.The device was connected to a gen11.During functional testing on the generator, although the device did activate, there was no audible feedback sound from the instrument when the clamp arm was fully closed.The instrument was tested with test media and it performed as expected.The instrument was disassembled to inspect internal components and the closure indicator was broken and not making contact with the moving trigger.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.No conclusion could be reached as to what caused this issue.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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