The device has not been returned.Per the customer, it is unknown if the device will be returned back for evaluation since it is in the bio-hazard container and may have been thrown out.Subsequently, the customer has been unresponsive to requests for follow up.For this reason a definitive root cause could not be determined.If the device, or additional information, becomes available at a later date the complaint will be updated accordingly.Based upon review of production records there appears to be no indication that manufacturing contributed to the reported failure as all devices met final acceptance criteria prior to release.Olympus will continue to monitor complaints for this device through regular trending activities as defined by olympus surgical technologies america quality management system procedure.
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It was reported during an emergent procedure while attempting to cauterize an gastrointestinal arteriovenous malformation (avm), the probe did not heat up.As a result, there was a delay in cauterizing the avm.The clinician was required to use a hot snare to cauterize the avm and complete the procedure.Other than the delay in the procedure, no other patient impact occurred.
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