On (b)(4) 2016, a fujifilm sales representative visited the facility and reported the following: after the facility staff reviewed current processes, it was discovered that the dilution ratio of steris prolystica 2x concentrate enzymatic pre-soak and cleaner was inadequate and inconsistent with the ifus for that product.It was determined that the manual cleaning sink had a volume of 8.5 gallons to the fill line.A measurement of the steris acu-sinq dosing system supplying automated dosing of prolystica 2x enzymatic cleaner was providing only a total of 0.75 fluid ounces per dosing cycle.According to manufacturer's ifus, the detergent should be diluted 1/8 to 1/2 fluid oz per gallon of warm water.The staff determined that the ratio of detergent to water was inadequate.The customer contacted steris, and made changes to the dosing system parameters to achieve 0.5 fluid ounces per gallon, for a total of 4.25 oz concentrated detergent (per 8.5 gals of water to the fill line in the sink).The facility reported that during this time they had instituted culturing of flexible endoscopes, no contaminated endoscopes were cleared for patient use until after negative culturing results were obtained.Therefore, the scopes which had tested positive were not used clinically (until they again cultured negative).To the best of our knowledge, no reports of infections or complications occurred post endoscopic procedures, and no harm came to any patients associated with these endoscopic procedures.The subject gastroscope was received at fujifilm medical systems endoscopy division on 02/15/2016, inspected and found to have a kinked biopsy channel, a kinked suction channel and slightly damaged, badly scratched and discolored plastic distal end cap.Fujifilm has made repeated requests to visit the facility to investigate the reported events.However, as of 03/10/2016 no approval for a visit has been received and limited answers have been provided to our specific questions.From the lack of detailed information available it is difficult to determine a definitive root cause, however, the use of a 6 fold less concentrated cleaning solution than recommended by its manufacturer combined with kinked instrument/suction channels which could limit or impede successful mechanical cleaning of channel surfaces cannot be ruled out as contributory factors to the inadequate reprocessing of the returned instrument.It should be noted that a total of 4 mdr's (nos.2431293-2016-00013 through 2431293-2016-00016) are being submitted for 4 endoscopes associated with the reported event at this healthcare facility.
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