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.Based on the results of the investigation, the event (reused disposable products) was confirmed, and the device did not meet the standard specifications.It was determined that the suggested event was caused by device handling.The device was inspected and was found to have been used, which was suggestive of black colored wire that was intact.At bow position (pulled), the wire was straight and in correct position.While attempting de-bowing the wire came out of the plane of the sheath, which was determined to be due to excessive push.The instruction manual identifies the following related verbiage which could have prevented the phenomenon: (drawing no.Gk6226 revision no.13): ·do not attempt to sterilize the instrument.Doing so could pose an infection control risk, cause tissue irritation, equipment damage, or malfunction.·the instrument is a single-use, disposable item.Do not reuse or attempt to sterilize it.Reusing the instrument could pose an infection control risk, cause tissue irritation or malfunction.Olympus will continue to monitor field performance for this device.
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