Model Number ENF-V3 |
Device Problems
Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the endoscope reprocessor displayed error e99 during reprocessing of the olympus rhino-laryngo videoscope.It was suspected that the error occurred because the number of oer-4 device used at the facility has increased sharply recently and acecide was replaced once a week.In addition, it was indicated, the acecide concentration check was not performed, and even after e99 occurred, the scope was reprocessed and used for the next patient.This medical device report (mdr) is being submitted to capture the reportable malfunction for the insufficient or incorrect reprocessing of the scope which was used in a procedure.There was no harm or user injury reported due to the event.This report is related to patient identifiers: (b)(6).
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Manufacturer Narrative
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It was reported that an olympus field service engineer (fse) spoke with the facility and impressed the importance of properly reprocessing the subject device using the indicated methods from the instructions for use (ifu).The facility state that they would consider improving their operations in the future.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed the reported e99 error code.The investigation also confirmed that the subject olympus rhino-laryngo videoscope was incorrectly/insufficiently reprocessed.The reprocessing was performed without checking the concentration of acecide.The reported event occurred because the end-user did not apply the reprocessing instructions specified in the instructions for use (ifu).The occurrence of the reported problem can be prevented by adhering to the following section of the ifu: ¿7.13 replacement of the solution.¿ the ifu instructs the user to: press the ¿stop¿ button to cancel the error when the solution is confirmed to be effective, and press ¿start¿ to continue cleansing.The error will be continuously alarmed until the solution is replaced even after the ¿stop¿ button is pressed.¿ olympus will continue to monitor field performance for this device.
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Event Description
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Additional information was received indicating that the reported event did not cause or contribute to any patient or user injury/harm.
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Manufacturer Narrative
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A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported event.The dhr confirmed that the subject device was shipped in accordance with the specifications.
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Search Alerts/Recalls
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