Model Number CV-180 |
Device Problems
Erratic or Intermittent Display (1182); Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
malfunction
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Event Description
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The customer reported the evis exera ii video system center image is shutting off and the image is grainy.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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Information has been requested but unknown at this time.Olympus technical assistance center (tac) support spoke to the customer to attempt troubleshooting the device.The customer was not in front of the equipment at the time of call.Furthermore, the customer was unable to provide serial number for the unit.The customer suggested sending in the unit however, tac explained that troubleshooting was first required.The customer mentioned having the same issue on several 180 scopes.Tac advised that the issue could potentially be related to maj-1430 or the cv-180 scope connection socket.The customer requested for an equipment to be sent to their location.Tac proceeded to transfer the call to repairs and loaners department for further assistance.The device has not been received to date.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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Manufacturer Narrative
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E2 e3- three attempts were made to obtain information, however the customer did not respond.This follow up report is being submitted to include the legal manufacturer investigation.The following sections were updated: h6, h10.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The flickering of the image was confirmed from the evaluation result.In this phenomenon, dust and water droplets adhered to the electrical contact with the scope.In addition, the cable connection was loose.It may have happened because there was something wrong with the board.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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