(b)(4).Date sent: 6/26/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # v94d2r.Additional information was requested and the following was obtained: "1.Was there an issue with any of the device seals? yes.2.Was insufflation unable to be maintained? yes.3.Was there an issue with the stopcock valve? unknown.".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 the 2b12xt device was returned with no damage in the external components.In addition, the packaging opened was returned along with the instrument.A leak test was performed and the device was noted to leak with the test probe inserted through the device.As each device is visually inspected and functionally tested during the manufacturing process, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what might have caused the reported event.The reported complaint was confirmed.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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