It was reported that during an unknown procedure, the trigger was stiff from the beginning.The trigger was especially stiff at 4th firing.The trigger did not return to home position after 8th firing., and it was returned by two hands.The device was used on the artery.Another device was used to complete the case.There were no adverse consequences to the patient.
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(b)(4).Date sent: 3/14/2023.Batch # v94j50.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 er420 device was returned with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the trigger could not be activated due to be jammed.The device was disassembled to evaluate the condition of the internal components and the trigger was found bent, not allowing the clips to fed into the jaws.In addition, 12 clips were found remaining inside the clip track.The damaged on the device could be that the internal ribs were being gauged by the feeder link, causing the trigger to experienced additional force that could interfere with the firing of the device.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 number, and no non-conformances were identified.
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