EASYSTE2020 ROUTER&CNTRL SYS

Additional Manufacturer Narrative

THE EVENT WAS CONSERVATIVELY CLASSIFIED AS A SERIOUS INJURY DUE TO THE PROCEDURE ALLEGEDLY BEING PROLONGED BY 30 OR MORE MINUTES. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

WHILE UNDER SEDATION FOR AN UNKNOWN THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE WAS UNABLE TO CAPTURE IN THE FIELD. THIS LED TO A SURGICAL PROLONGATION GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS A SERIOUS INJURY; HOWEVER, THERE IS NO EVIDENCE THE PATIENT SUFFERED ANY SERIOUS INJURY OR ADVERSE EFFECTS FROM THE PROLONGED PROCEDURE. OLYMPUS MADE MULTIPLE ATTEMPTS TO RECEIVE MORE INFORMATION FROM THE CUSTOMER WITHOUT SUCCESS. THUS, CORRECTING B1, B2, AND H1. B1 SHOULD NOT BE MARKED AS AN ADVERSE EVENT, AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED. THE H6 MEDICAL DEVICE PROBLEM REPORTED, AND OTHER FINDINGS WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF IT WERE TO RECUR. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION AND THE COMPLAINT WAS UNABLE TO BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AND THE MOST PROBABLE CAUSE OF THE COMPLAINT IS NO PROBLEM DETECTED. EITHER IT WAS NOT CONFIRMED THAT THERE WAS A PROBLEM WITH THE DEVICE, OR IT WAS CONFIRMED THAT THERE WAS NO PROBLEM WITH THE DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.