(b)(4).Date sent: 12/1/2023.D4: batch # a9ce85.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that b12srt device was returned outside it's packaging opened and with no apparent damage.In addition, universal seal was returned unlatch from the sleeve.In an attempt to replicate the reported incident, the device was functionally tested to detect any reducer attachment removal issues.Upon evaluation of the device had the universal seal latch onto the sleeve assembly.In addition the obturator latch onto the universal seal as well.The device was visually inspected and no damaged found on the sleeve.The device was fully functional according to the manufacturing requirements.The event described could not be confirmed as the device performed without any difficulties noted.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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