SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED TO STERIS FOR EVALUATION. INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE TWO OF THE ELASTIC BANDS TO THEIR SMARTBAND MULTI-BAND LITIGATION KIT RELEASED AT THE SAME TIME AND ONE OF THEM BECAME STUCK AT THE GASTROINTESTINAL JUNCTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY TO LOCATE THE ELASTIC BAND. NO REPORT OF INJURY.