Model Number CYF-VH |
Device Problems
Contamination (1120); Failure to Clean Adequately (4048)
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Patient Problem
Bacterial Infection (1735)
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Event Date 11/30/2023 |
Event Type
Injury
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Event Description
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The customer reported to olympus, three patients became infected with pseudomonas after the cysto-nephro videoscope was used on them for a diagnostic cystoscopy.The event occurred in the operating room, emergency room, and gastrointestinal lab.The infection started in november and the patients are better after receiving intravenous (iv) antibiotics.The intended procedure was completed for each patient.The patient's anesthesia was not extended as a result of the issue and the outcome of the procedures was not affected.The device was inspected prior to use on each patient per the instructions for use (ifu) and was replaced during the event.Related patient identifiers: (b)(6).
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Manufacturer Narrative
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The device has been received and is pending evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.This report has been submitted by the importer under this mdr report number 2429304-2024-00001.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the third-party culture testing, device evaluation, and the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the following reportable defects were confirmed: 1.Heavy residue around the bending section cover (a-rubber).2.Residue around the objective lens (ob).3.Heavy residue around the light guide lens.4.Residue in the insertion tube.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Olympus sent the subject device for third-party culture testing, and the reported microorganism (pseudomonas) was not detected.In addition, an olympus representative conducted an onsite visit, and identified that the facility did not follow the reprocessing procedures recommended by olympus.Therefore, based on the results of the investigation, it was determined that the reported event was caused by insufficient reprocessing of the device due to deviation from the instructions for use (ifu) manual.The event can be detected/prevented by following the instructions for use (ifu) in section: ¿cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual¿ this supplemental report includes a correction to d9 and g2 from the initial medwatch.Also, an update has been made to h3.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 the legal manufacturer's further investigation findings.Based on the additional findings, it was identified that the subject device is related to the reported patient infection.Per olympus expert review, it was determined that inadequate reprocessing resulted in large amounts of foreign material on the endoscope which likely caused the patient infection.This supplemental report also included additional information received regarding the event.B5 updated accordingly.Also, a correction has been made to h6 to provide information that was inadvertently not included in the previous submission.
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Event Description
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It was reported that the subject scope was cleaned and disinfected after the procedure, prior to returning the device to olympus for testing and evaluation.
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Manufacturer Narrative
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This supplemental report is being submitted to provide information that was inadvertently not included in the previous submission.Per third-party testing performed by olympus, it was previously reported that the suspected microorganism (pseudomonas) was not detected.However, an unknown number of bacteria, bacillus thuringiensis, was detected in the device¿s insertion section.H6 code has been added accordingly.
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Search Alerts/Recalls
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