It was reported that, during reprocessing, the tracheal intubation fiberscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
|
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer cleaning disinfection and sterilization (cds) processes, results of third-party testing, and the lms final investigation.The lm reviewed the customer provided cds processes where information to judge deviation from ifu was not identified.The user facility provided the following result of the culture test, performed at the third-party labs: <1st test> sampling date: nov.28, 2023 sampling from: unspecified cfu: 100cfu bacterial identification: gram positive bacilli <2nd test> sampling date: dec.11, 2023 sampling from: unspecified cfu: 100cfu bacterial identification: gram positive bacilli <3rd test> sampling date: dec.20, 2023 sampling from: unspecified cfu: 7cfu bacterial identification: gram positive bacilli cfu: 100cfu bacterial identification: gram positive bacilli <4th test> sampling date: mar.14, 2024 sampling from: unspecified cfu: 2cfu bacterial identification: gram positive bacilli a review of the device history record found no deviations that could have caused or contributed to the reported issue.It was noted during additional follow-up with the user facility that the subject device was not quarantined after microbiological sampling and was used on an unknown number of patients.The reported event was not confirmed as the scope was not microbiologically tested by olympus.The following is included in the device instructions for use (ifu): ¿ifu (reprocessing manual) states ¿failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each examination can compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each examination the endoscope must undergo thorough the manual cleaning followed by high-level disinfection or sterilization.¿ to warn about inappropriate reprocessing.Operation manual 3.3.2 states: ¿please read before use: warnings and cautions, reprocessing manual 1.1.3, 2.2.1 and 5.5.1 about preventive measures of peeling off coating on the insertion section.¿ olympus will continue to monitor field performance for this device.
|