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This supplemental report is being submitted to provide additional information received from the olympus canada clinical nurse.As part of our investigation, an olympus canada clinical nurse was dispatched to the user facility multiple times to observe the facility¿s reprocessing methods and provide training if necessary on sept.17, 18, 19, 2018.At which time the clinical nurse noted that the facility was following an instruction sheet dated from 2010, to perform bedside cleaning on the ebus scope.The facility was performing the first and second steps of, aspirating enzymatic for 30 seconds followed by 10 secs of air.They are now to follow the 10 seconds of air, with the aspirating of water for 30 seconds followed by an additional 10 seconds of air.The same deviation was noted with the balloon channel, the facility was performing the aspiration of 90 cc of enzymatic, followed by 90 cc of air.They are now to follow the air, with the aspiration of 90cc water 3x and 90cc of air 3x.The clinical nurse reported this was pointed out to the facility¿s staff, along with leaving a new updated sheet on the ebus pre-cleaning protocol.A followed up email including the pre-cleaning protocol sheet in english and in french was also sent to the user facility.Additionally, the olympus canada clinical nurse was also dispatched to the user facility to provide additional education and in-service to the facility¿s endoscopy department staff.During the demonstration portion of the course, the clinical nurse provided a demonstration on the following scope/ category(family) of endoscopes): gi endoscope: colonoscope, bronchoscope and duodenoscope of the 180 series.The clinical nurse reviewed the leak testing and manual cleaning of the endoscopes, as applicable to the use of the oer-pro and also demonstrated the placement of the endoscopes in the oer-pro for the gi scope as well as the duodenoscope (tjf).The bronchoscope was not placed in the oer-pro as they use steris system 1 for that.Also, as a part of the course, a test is to be completed by the participants to assess their knowledge.The participants that did not have sufficient mark were taken aside and their test reviewed with them entirely, individually, to make sure that they understood the content and the errors made.On december 10, 2018, the facility¿s endo department manager, contacted the olympus clinical nurse to request a return visit to the user facility to provide the staff an education course for the care and handling of the facility¿s endoscopes.The endo department manager mentioned that over the past weeks the facility had a large number of scopes damaged (around 15) and wanted to ensure that her staff was trained properly.The clinical nurse was unavailable to schedule a course and recommended the facility contact the local olympus sales to schedule an in-service.Finally, on february 6 2019 the clinical nurse was dispatched to the user facility again to observe the facility¿s reprocessing methods and provide additional training if necessary.The clinical nurse reported that the observation of a gastroscopy, colonoscopy, bronchoscopy included: the procedure room set-up, procedure, pre-cleaning, reprocessing and storage practices was performed.The clinical nurse noted the following findings: harsh handling during room set-up by procedure room staff.Handling of the endoscopes by procedure room staff also harsh.Pre-cleaning following procedure: not consistently, properly completed.Scope placement in transport bin not adequate.Reprocessing was timely and as per the all other steps ifu with the exception of the pre-cleaning.In addition, during the onsite observation visit, the reprocessing of the ebus scope was reviewed with one of the reprocessing technician and found to be in accordance with the olympus reprocessing instruction for the bf-uc180f.
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Olympus received additional information from the user facility that state the patient¿s biopsy from the mediastinal lymph node cultured positive for the following microbial organisms: streptococcus constellatus, parvimonas micra and prevotella species.The patient was treated with antibiotics.The user facility has not reported the patient incidents to the aer manufacturer.According to the user facility, a maintenance/service request was placed on december 08, 2018 with the aer manufacturer.However, due to scheduling the facility¿s biomedical engineer inspected the aer and confirmed its specifications.The device was returned to olympus for evaluation.An olympus boroscope was used to perform a visual inspection on the returned device and found no signs of foreign material inside the scope¿s channels.A scratch mark was noted inside the channel from the bending section side.The distal end was inspected and found the scope¿s bending section cover overlapping.Further inspection found the bending section glue peeling off from the top and lower section of the scope.There was a dent noted in the middle section of the insertion tube.The scope passed the leak test.Based on the investigation there was no evidence of any foreign material or substance inside the instrument channel.The cause to the overlapping on the bending section cover is due to mishandling.The instruction manual provides users several warnings to prevent equipment damage.¿do not twist or bend the bending section with your hands.Equipment damage may result.Do not attempt to bend the endoscope¿s insertion section with excessive force.Otherwise, the insertion section may be damaged.¿.
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