Model Number CD-B620LA |
Device Problem
Output Problem (3005)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The subject device was not received for evaluation.The user facility conveyed that they did not have the unit to return.No further details were provided.If additional information becomes available this report will be supplemented accordingly.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system, and process changes.A capa has been opened to manage the actions related to remediation of this issue, and any required reporting.
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Event Description
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It was reported that the device did not heat up.The reported issue occurred when the unit was used with bi-coagulation setting.The event occurred during set up, and preparation for use.The user facility biomedical engineer confirmed that the other probes are functional, and with no issues.There was no patient involvement on this report.No user harm reported.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the trend analysis review and investigation conclusion.The device was discarded by the customer and not returned to olympus for evaluation.Therefore a definitive root cause could not be determined.Review of dhr or manufacturing procedures could not be completed as the lot number is unknown.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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