Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.The device appeared to be in good condition with the exception of minor scratches along the surfaces.The device was attached to running fluid to verify the leakage location on the device.No leaks were observed when the running fluid was connected to the inflow and outflow ports.Since the failure experienced by the customer could not be reproduced, no root cause is available for the reported failure.At this point, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
|
This is report 2 of 3 for the same event.It was reported by the affiliate in (b)(6) that during shoulder arthroscopy, it was observed that three i/o flow sheath-storz devices were leaky even though they changed the o-rings.There was a three-minute delay in the surgical procedure.There was a competitor device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|