Model Number URF-P6 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Olympus followed up with the customer to obtain additional information regarding the facility¿s cleaning disinfection and/or sterilization (cds) methods per the customer¿s cds form, during pre-cleaning, the customer performs aspiration of water through the instrument channel /suction channels and the air/water channel.Salvanios detergent is used during pre-cleaning.During manual cleaning, brushing is performed in the working/suction channel, instrument channel port, balloon channel and the distal end/elevator area.Brushes /swabs used during manual cleaning are the lta medical ref: sr121525, set of 3 brushes with swab.Manual disinfection is performed using anioxyde 1000.The scope is stored horizontally in its disinfectant box with sterile drapes and is serviced/maintained by olympus.The scope is sterilized every six days using sterilized using anioxyde 1000.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.
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Event Description
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Olympus (ofr) was informed that after a microbiologival routine control on the customer uretero-reno fiberscope which was carried out by french regulation, the user detected an unexpected contamination, (total flora > or = 13 ufc /100ml).There was no report of patient death, injury or infection.The scope was returned to olympus subsidiary for further hygiene microbiological investigation (hmi).
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Event Description
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Olympus (ofr) was informed that after a microbiological routine control on the customer uretero-reno fiberscope which was carried out by french regulation, the user detected an unexpected contamination, on (b)(6) 2022 sampling from the biopsy channel resulted in 3cfu (colony forming units) of an unknown organism.On (b)(6) 2022 sampling from the biopsy channel resulted in 2cfu of an unknown organism.On (b)(6) 2022 sampling from the biopsy channel resulted in 2cfu of an unknown organism.There was no report of patient death, injury or infection.The scope was returned to olympus subsidiary for further hygiene microbiological investigation (hmi).
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Manufacturer Narrative
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Correction of the initial report.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with ifu before repair, the results conformed to the regulation¿s recommendation.The following is included in the device ifu: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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