The product was disposed of by the hospital and is no longer available for return.Without the return of the device, an investigation cannot be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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During preparation for a thrombectomy procedure, an indigo system separator 8 (sep8) was inadvertently dropped on the floor as the nurse was passing it to the technician.The sep8 was dropped on the floor prior to use and therefore, was not used in the procedure.The procedure was completed using a new sep8.
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