This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide additional information received through follow-up (b5 and expert reviews).The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the subject device was not returned, and the subject device was not cultured, therefore; olympus was not able to judge the relation between the subject device and the event from the following investigation results.Additionally, it is likely the reported event occurred due to a misunderstanding of device handling and reprocessing steps between the user and olympus¿s recommendation.However, the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ additional information based on olympus expert reviews: it is very possible for biofilm to form in between the segments of the maj-891, as this piece has been linked to outbreaks.It is recommended to obtain microbiological samples of the involved endoscopes and the involved maj-891 (and the loose parts that need to be brushed).Olympus will continue to monitor field performance for this device.
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It was reported by the customer that after the olympus in-service training, there have been no further related issues at the facility.The forceps/irrigation plugs (maj-891) used at the facility are disassembled and cleaned correctly.The patients involved in the events are reportedly ¿fine after treatment,¿ and currently in ¿good¿ condition.It was confirmed that the patients did not develop bacteremia or sepsis and did not require admission to the icu.Furthermore, the facility reported receiving reprocessing training when the flexible cystoscope (cyf-v2) was introduced for use.
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