OLYMPUS ENDOSCOPE

Description of Event or Problem

THE USER FACILITY REPORTED THAT A PT HAD BEEN ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF CHEMICAL COLITIS FOR AN UNSPECIFIED PERIOD OF TIME FOLLOWING AN ENDOSCOPIC EXAM. THE PT WAS SAID TO HAVE BEEN DIAGNOSED WITH CHEMICAL COLITIS BASED UPON A CT SCAN, BUT WAS NOT RE-EXAMINED ENDOSCOPICALLY. THE PT WAS SAID TO HAVE BEEN ADMITTED TO THE HOSPITAL FOR THREE DAYS, BUT HAS BEEN DISCHARGED AND WAS SAID TO BE DOING FINE.

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE USER FACILITY BY PHONE AND IN WRITING TO OBTAIN ADDITIONAL DETAILED INFO REGARDING THE EVENT, BUT LIMITED DETAILED INFO HAS BEEN PROVIDED TO DATE. THE PHYSICIAN REPORTEDLY INFORMED THE PT THAT THE CAUSE OF THE COLITIS WAS DUE TO INSUFFICIENT REPROCESSING, BUT OTHER STAFF MEMBERS REPORTEDLY DISAGREED WITH THIS ALLEGATION. THE USER FACILITY DECLINED TO RETURN THE SUBJECT DEVICE TO OLYMPUS FOR EVAL. THE FACILITY CONTACT PERSON STATED THAT THERE WERE NO PROBLEMS WITH THE DEVICE AND THAT THE LOG OF THE AUTOMATIC ENDOSCOPE REPROCESSOR (AER) USED TO PROCESS THE DEVICE SHOWED THAT A FULL REPROCESSING CYCLE WAS COMPLETED PRIOR TO THE USE OF THE SUBJECT DEVICE ON THE PT. THE FACILITY CONTACT PERSON REPORTED THAT THE SUBJECT DEVICE HAD BEEN USED IN SUBSEQUENT PROCEDURES AND THERE HAVE BEEN NO PROBLEMS REPORTED. THE CAUSE OF THE PT'S OUTCOME CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS BEEN DISPATCHED TO VISIT THE USER FACILITY TO PROVIDE IN-SERVICE TRAINING ON APPROPRIATE ENDOSCOPE REPROCESSING PROCEDURES. IF SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.