The yellow suture boot split and fell off of the device into the patient's abdomen requiring the surgeon to manually remove the suture boot from the surgical site during the procedure.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.There was no report of any adverse patient consequence, no effect on the patient's stability, and no additional intervention required as a result of the incident.A photo was received for evaluation which observed the suture boot that is placed on the instrument is cracked starting at the top and continuing to split down the side of the suture boot almost to the bottom.It appears that only one of the two suture boots on the instrument was cracked and the crack is occurring on the interior side of the instrument clamps that close together and meet the other clamp.There does not appear to be any other physical damage to the suture boots.The actual sample was not returned to the manufacturer for evaluation.A definitive root cause for the reported issue could not be determined at this time.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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