(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: reoperation was performed, and the patient¿s condition became stable postoperatively.The stratafix which had been used during the primary operation could not be found on the sutured area during the reoperation.- the surgeon commented there is a possibility that the tissue was torn by the stratafix because the patient¿s tissue on which the stratfix was used was thinner than usual.What tissue was the stratafix symmetric suture used on? => no information.What was the condition of the tissue when the suture was placed (diseased, weak, healthy)? =>no information.How was the stratafix symmetric placed? =>no information.Was the fixation tab intact when the suture was placed in the patient? =>no information.Can you explain ¿stratafix which was used in primary surgery became loose¿? =>the stratafix was used in the primary operation.During the reoperation, it was found that the stratafix was loose.Was the air leakage persistent or new at leak at 3 weeks post op? =>the doctor found it at 3 weeks post op.What was the indication for the re-operation? =>it was found that the stratafix was loose.Air leak was observed.What was the date of the second procedure? => (b)(6) 2018.Could you describe the appearance of the suture during the second procedure? =>it was loose.Was the suture intact and pulled through the tissue? =>the doctor couldn't find the stratafix, so it wasn't retrieved from patient.Do you have the status of suture for evaluation? =>no.The suture was lost during the reoperation.What is the current condition of the patient? => the patient has been stable since the reoperation.".
|