OLYMPUS SIGMOFIBERSCOPE

Additional Manufacturer Narrative

OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY STAFF REPORTED THAT THERE WAS NO APPARENT PROBLEM WITH THE SCOPE USED DURING THE PROCEDURE, BUT THE PHYSICIAN HAD REPORTEDLY EXPERIENCED MINOR DIFFICULTY WITH THE AIR/WATER FLOW DURING THE PROCEDURE. AFTER REPLACING THE AIR/WATER VALVE, NO FURTHER ISSUES WERE REPORTED. THE STAFF REPORTED THAT THEY DO NOT SUSPECT THE SIGMOIDOSCOPE TO BE THE CAUSE OF THE PATIENT'S OUTCOME. THE PROCEDURE WAS REPORTEDLY COMPLETED UTILIZING THE SAME DEVICE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION INDICATED THAT THE AIR/WATER FLOW AND CAPACITY ON THE DEVICE WAS WITHIN STANDARD. THE INTERNAL CHANNEL OF THE DEVICE WAS EXAMINED USING A BOROSCOPE, AND IDENTIFIED A YELLOWISH AND PINKISH STAIN ON THE EXTERNAL PORTION OF SUCTION TUBE. THERE WERE WHITE RESIDUES AND DEBRIS INSIDE THE CHANNEL MOUNT AND SUCTION CYLINDER UNIT OF THE DEVICE. AS PART OF THE INVESTIGATION INTO THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS THE FACILITY'S REPROCESSING PRACTICES AND TO PROVIDE IN-SERVICE TRAINING IF NECESSARY. THE EXACT CAUSE OF THE PATIENT'S OUTCOME COULD NOT BE DETERMINED. THIS REPORT IS BEING SUBMITTED AS AN MDR IS AN ABUNDANCE OF CAUTION.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) A DAY AFTER HAVING UNDERGONE A THERAPEUTIC SIGMOIDOSCOPY. THE PATIENT REPORTEDLY EXPERIENCED ABDOMINAL PAIN, MINOR RECTAL BLEEDING, FEVER WITH CHILLS, AND MUCOUS IN HER BOWEL MOVEMENTS FOLLOWING THE PROCEDURE. BLOOD TESTS WERE PERFORMED, AND THE PATIENT WAS SAID TO HAVE BEEN RELEASED FROM THE FACILITY ON THE SAME DAY. THE ATTENDING PHYSICIAN REPORTEDLY CALLED THE PATIENT THE DAY FOLLOWING THE ER VISIT, SUBSEQUENT TO RECEIVING THE RESULTS OF ALL BLOOD TESTS. THE RESULTS OF ALL BLOOD TESTS WERE SAID TO BE NORMAL. HOWEVER, THE PATIENT REPORTED HAVING THE SAME SYMPTOMS, BUT WITH REDUCED DIARRHEA AND SCANT BLEEDING.