Model Number CLV-190 |
Device Problems
Communication or Transmission Problem (2896); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device was returned for investigation.Upon evaluation of the device, a b30 scope communication error due to defective s-socket and damaged tank socket were noted.The probable cause of the malfunction was due to wear and tear.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
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Event Description
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The customer reported the evis exera iii xenon light source does not recognize any endoscope.In addition, an e30 error was displayed.There was no patient involvement, no harm or user injury reported due to the event.
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Manufacturer Narrative
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This follow up report is being submitted to include the device history record(dhr) review and results from the legal manufacturer investigation.The following sections were updated: b5, h2, h4, h6 and h10.The legal manufacturer performed the dhr review for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.The root cause was unable to be identified however, it is surmised that the b30 error occurred because the scope socket was out of order.Olympus will continue to monitor complaints for this device.
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Event Description
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It was further reported that the problem was first identified during a gastroscopy procedure.The device was changed however, the intended procedure was not completed.There was no injury or harm caused to the patient.
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Search Alerts/Recalls
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