The manufacturer followed up multiple times with the user facility via telephone and in writing to obtain additional information regarding the reported patient infection but with no results.As part of the investigation, an endoscopy support specialist (ess) visited to the user facility on may 10, 2019 to provide a reprocessing training.The ess completed a clean disinfection and sterilization/care and handling in-service on a tjf-q180v endoscope with the staff.In-service included all cleaning, disinfecting, and sterilization information contained in the instruction manual.Provided repair reduction information.Each attendee performed a return demonstration.The scope was sent to an independent laboratory for microbial testing.The scope was cultured and the test results indicated the scope's distal end and elevator mechanism tested positive for streptococcus salivarius.The scope was then ethylene oxide (eto) sterilized and returned for a device evaluation.A visual inspection was performed on the received condition and found red and black spots inside the channel when inspected.The red spots were found inside the instrument channel from the bending section side.The instrument channel was inspected further and found scrape marks and kinks inside the channel from the biopsy port and bending section side.The suction channel was inspected and there was no evidence of kinks, marks, or foreign material.Additionally, the image was inspected and the image of the scope is normal.The service group noted the scope failed the leak test from the instrument channel and the bending section cover glue was cracked.A review of the scope¿s instrument history records indicate the scope was purchased on december 20, 2015 and was last serviced in november 13, 2018.The exact cause of the reported patient infection could not be confirmed.However, as a preventive measure, the reprocessing manual states, ¿an insufficiently cleaned, disinfected, or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them." if additional information becomes available, this report will be supplemented accordingly.
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