The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
|
During preparation for a thrombectomy procedure, the scrub technologist inadvertently dropped an indigo system aspiration tubing (tubing) on the floor when the packaging was opened.Consequently, the tubing became contaminated.The tubing was dropped prior to use and therefore, was not used in the procedure.The procedure was completed using a new tubing.
|