The customer reported to olympus, the flexure of the oes hysterofiberscope was crushed by strong impact when washed after a hysteroscopy procedure, and black fluid was leaking from the forceps channel.It was also reported that the black fluid may have leaked into the patient during testing.The procedure was completed with the same device.No health problems were reported by the patient who underwent testing.As part of the cleaning, disinfection and sterilization (cds) process, manual cleaning and disinfection was performed onsite by the customer according to the instructions for use.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the legal manufacturer¿s investigation, the reprocessing procedure of the facility did not deviate from the instruction manual, and the device evaluation could not confirm the black liquid from the inside of the scope.Therefore, a definitive root cause could not be determined.During inspection and testing, service found a leak due to a perforation in the instrument/forceps channel.Due to buckling and deformation of the instrument/forceps channel tube, the channel cleaning brush could not be inserted smoothly, and the forceps could not be inserted.The insertion tube was crushed due to external factors.The connecting tube had a dent, and the bending tube was damaged.The image guide had significant breakages due to physical stress, and the rubber adhesive was deteriorated and chipped due to the cds processes over time.The angle of curvature was insufficient due to the stretching of the angle wire, and the bending angle in the up direction was out of specification due to stretching of the angle wire.A leak was observed in the light guide bundle, and the light guide cover glass and connector had corrosion.The light guide lens had discoloration.The light guide bundle was slipping.The control unit body demonstrated fluid ingress.The universal cord was scratched, dented, and sticky, due to wear and stress from the cleaning/disinfecting/sterilization (cds) processes over time.The grip and up/down plate were sticky due to deterioration/discoloration from the cds processes over time.The adjustment ring indicator was peeling.Scratches were observed on several device components due to wear.Olympus will continue to monitor field performance for this device.
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