(b)(4).Date sent: 12/8/2023.D4: batch # a9dn0g.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 revealed that the el5ml device was returned with no apparent damage.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 4 conforming clips. upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended. although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: do not excessively twist or torque the instrument jaws when positioning or firing the instrument on a tubular structure or vessel.Excessive twisting or torquing may result in clip malformation.Do not insert the clip applier through a trocar if a clip is present in the jaws.This may result in clip malformation, dislodged clips, or damage to the instrument.If a clip is present in the jaws, fully squeeze the trigger against the handle, then fully release the trigger to release the clip from the jaws before inserting the device through the trocar.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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It was reported that during an unknown procedure, the clip could not be fed into the jaw, so the surgeon grasped the trigger forcibly, but the jaws became not to open and could not be used.The device was used less than 10 firings.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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