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| Model Number TJF-Q190V |
| Device Problem
Device Reprocessing Problem (1091)
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| Patient Problem
Unspecified Infection (1930)
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| Event Date 10/17/2022 |
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Event Type
Injury
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Manufacturer Narrative
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The suspect device has been returned to olympus and sent to a third party for microbial contamination evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304-2022-00124.
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Event Description
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The customer reported to olympus, after three therapeutic procedures with the same subject device, three patients had unspecified infections.The device was then removed from use.The patients tested positive for: e coli, pseudomonas aeruginosa and candida albicans from an unknown culture source.The facility did not specify which patient had each microorganism.No atp testing was performed.The scope was reprocessed (b)(6) 2022, no delay in the start of pre-cleaning, water was aspirated through the instrument/suction channel with a suction pump, no abnormalities with the reprocessing accessories, manual cleaning was performed within an hour after the procedure or pre-soaking was completed, device passed the leak test, ezol detergent used, and all appropriate areas of the scope were brushed (air/water/suction/biopsy valve; suction, air/water, biopsy port, elevator).The customer's last reprocessing in-service by olympus was (b)(6) 2021 and there have not been any changes in personnel since then.The endoscope is being stored in a drying cabinet, hanging vertically with knobs on the free position.The aer used: medivators advantage plus ¿ serial #: (b)(4).Detergent and disinfect solutions used are intercept/rapicide pa.All channels were connected with tubes when the endoscope was connected to the aer.On 15 nov 2022, an olympus team member was dispatched and discussed the patient infections with the reprocessing technician.The reprocessing technician was unaware of anything unusual about the scope.The observation/in-service could not be performed that day and will take place (b)(6) 2022.This event includes 3 reports: (b)(6) : patient 1.(b)(6) : patient 2.(b)(6) : patient 3.
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Manufacturer Narrative
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This report is being supplemented to provide additional information obtained.On november 23, 2022, the olympus endoscopic support specialist (ess) returned to the customer¿s site and found there were several areas where the documented reprocessing instruction was not followed as it relates to the sequence of the these steps: - movement of the elevator following brushing; - suction flushing; - external cleaning (wipe of surfaces); - improper use of the distal end flushing adapter (the adapter and syringe not immersed in detergent while flushing).The wall cleaning guide is posted and available to follow.Ess reviewed missed or improper steps with the reprocessing staff and the clinical infection prevention education specialist.Ess emailed findings to endoscopy manager requesting a schedule to complete a second reprocessing with the staff.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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Event Description
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Three attempts were performed to obtain additional information regarding this event, but no response was received from the customer.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the results of third-party testing, the device evaluation, and the legal manufacturer's final investigation.The subject device was reprocessed and sent by olympus to a third-party lab for culture testing.Samples were obtained from the scope¿s insertion section and the distal end and elevator mechanism.Although the colony forming units (cfu) are unknown, the following bacterium were found in the insertion section: micrococcus luteus and cellulomonas species.In addition, although the colony forming units (cfu) are also unknown, the following bacterium were found in the distal end and elevator mechanism: acinetobacter radioresistens, pseudomonas nitrititolerans, and cellulomonas species.The device was returned under related record (patient identifier # (b)(6) and evaluated.No abnormalities were found that could have led to the positive culture.A few non-reportable defects were observed during the inspection of the device.However, these defects alone are not considered severe enough to cause a potential adverse event.The non-reportable issues noted during the inspections are as follows: light surface scratches and discoloration on the wall of the biopsy channel light scratches on the stainless-steel portion of distal end.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.Although the user did not perform a culture test on the suspected device, there was report of patient infections after the use of the device is multiple procedures.However, after a review of the reprocessing steps provided by the user, deviation from the instructions for use (ifu) was confirmed.Although a relationship between the subject device and the patient infections is unknown, it is likely that the reported issues occurred due to the user¿s misunderstanding of device handling and proper reprocessing of the device as instructed by olympus.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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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information received from the facility (per capa-201237 interview).The facility reported that at the time of the event, device reprocessing was conducted according to the olympus instructions for use (ifu) manual.However, after the reported event, (during reprocessing observation) it was identified that there were deviations from the reprocessing procedures.The facility did not properly follow the reprocessing steps outlined in the olympus ifu manual.Areas where deviations from the ifu reprocessing steps were identified are as follows: 1.Movement of the elevator following brushing.2.Suction flushing.3.External cleaning (wipe surfaces).4.Wall cleaning guide posted and available to follow.5.Improper use of the distal end flushing adapter.6.The adapter and syringe are not immersed in detergent while flushing.Once cleaned, the endoscopes are dried in an endoscope cabinet (logiquip with air flow).To prevent future occurrences, the facility has confirmed with olympus the correct reprocessing steps and has verified those procedures within the facility.Reprocessing guide wall posters and the ifu¿s have been provided and posted in the reprocessing room.Also, pre-cleaning instructions are available in the procedure room.Visual inspections of the endoscope are performed prior to the procedure and during manual cleaning of the device.At this time, an inspection is conducted to ensure the glued areas are intact between the control and insertion tube, as well as evaluating the tip of the scope.The device is sent for repair when defects are found by the technician before or after the procedure, or when requested by the physician.Devices in need of repair are stored in an endoscope cabinet.Per the facility, training is conducted in-house with a super or champion user.Newly hired staff are not trained by the manufacturer (olympus) until an annual in-service refresher training is scheduled.An onsite education coordinator oversees staff training needs for specific departments within the facility.The coordinator conducts periodic audits and olympus is invited to provide in-service training annually.Based on the additional information obtained by olympus, a relationship between the subject device and the reported patient infection could not be confirmed.Therefore, there is no change to the previously reported legal manufacturer¿s investigation findings.
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Manufacturer Narrative
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Investigation activities were performed by olympus (per capa-201237), and the customer provided the following additional information: the product (tjf-q190v) was delivered on 30dec2020.An annual inspection of the device was performed in march 2022.There were device repairs performed to correct an a-rubber adhesive crack in may 2022, and subsequently in june/july 2022.The reported event occurred on 17oct2022, 98 days after the completion of the device repair.It was reported by the olympus endoscopy support specialist (ess) that all reprocessing information was provided to the customer in the form of a reprocessing manual, wall poster guides, and in-service training.However, the customer was unaware of their deviations from the reprocessing steps outlined in the instructions for use manual as detected by the olympus ess.It was noted that several areas (of the reprocessing steps) were not followed.Prior to the reported event, the following training was provided by olympus: reprocessing in-service was conducted by an olympus ess on 13feb2021.The in-service was conducted in accordance with "ontrack reprocessing in-service/customer competency for the tjf-q190v endoscope (rc7278)." although several staff members participated in the in-service, it is unclear if all the reprocessing staff attended the training.After the reported event, in-service training sessions were conducted in november 2022 and june 2023.In november 2022, only pre-cleaning was covered in the in-service training.However, all reprocessing procedures were covered in the june 2023 in-service training.The in-service was conducted in accordance with the "ontrack reprocessing in-service/customer competency for evis exera iii duodenovideoscope tjf-q190v (rc8566).¿ although several staff members participated in the in-service, it is unclear if all the reprocessing staff attended the training.It is also unclear if device pre-use inspection checks were conducted at the time of the infection outbreak.Currently, the device is inspected by hand before use.Also, leakage tests are conducted after each case.Furthermore, it was confirmed that there was no change in the reprocessing staff at the facility since the olympus ess onsite visit.It is unknown if there has been any further training within the facility.
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