Description of Event or Problem · 0
OLYMPUS RECEIVED A VOLUNTARY MEDWATCH REPORT REGARDING THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE, STATING THE USER FACILITY HAD BEEN NOTIFIED BY THE STATE OF AN E.COLI PATIENT THAT WAS HOUSED INPATIENT. UPON NOTIFICATION, CHART REVIEW AT THE USER FACILITY WAS INITIATED TO DETERMINE POSSIBLE CAUSES. DURING SAID CHART REVIEW, IT WAS FOUND THAT TWO SCOPES WERE USED ON MULTIPLE PATIENTS THAT HAD BEEN CONFIRMED TO HAVE NDM E. COLI. BOTH SCOPES HAVE BEEN SEQUESTERED FOR EXAMINATION. THE FACILITY HAS BEEN CONTACTED MULTIPLE TIMES TO CLARIFY THE EVENT AND PATIENTS, BUT NO RESPONSE HAS BEEN RECEIVED. SIX MDRS ARE REQUIRED FOR THIS EVENT, AS MULTIPLE SCOPES AND MULTIPLE PATIENTS WERE INVOLVED: PATIENT IDENTIFIER (B)(6) IS FOR PATIENT 1 (42 YEAR OLD FEMALE) FOR GIF-HQ190/ 2201760. PATIENT IDENTIFIER (B)(6) IS FOR PATIENT 2 (UNKNOWN PATIENT) FOR GIF-HQ190/ 2201760. PATIENT IDENTIFIER (B)(6) IS FOR PATIENT 3 (UNKNOWN PATIENT) FOR GIF-HQ190/ 2201760. PATIENT IDENTIFIER (B)(6) IS FOR PATIENT 1 (42 YEAR OLD FEMALE) FOR GIF-HQ190 / 2517646. PATIENT IDENTIFIER (B)(6) IS FOR PATIENT 2 (UNKNOWN PATIENT) FOR GIF-HQ190 / 2517646. PATIENT IDENTIFIER (B)(6) IS FOR PATIENT 3 (UNKNOWN PATIENT) FOR GIF-HQ190 / 2517646. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6) .