It was reported, while reprocessing the gastrointestinal videoscope using the endoscope reprocessor, it was discovered that the connecting tube had been modified.It had been cleaned with non-regular materials.The issue occurred during reprocessing.There were no reports of patient harm.Related patient identifiers: (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the user not thoroughly reading the instruction manual, leading to an incorrect implementation of reprocessing of the device with a modified connecting tube.The suggested event can be detected and prevented in line with the the instructions for use (ifu) below.: the oer-4 instruction manual operation manual important information - please read before use never disassemble or modify this equipment.Doing so could result in operator or patient injury and/or equipment damage or malfunction.If it is considered necessary to perform repair, take actions according to chapter 8, ¿troubleshooting and repair¿.If the problem still exists, contact olympus.Olympus will continue to monitor field performance for this device.
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