Model Number 801-000 |
Device Problems
Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a lithovue touch pc was attempted to be used on (b)(6) 2021.Touch pc could not power on, tried different socket and still would not power on.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: device problem code a27 is being used to capture the reportable issue of aborted/unknown procedure outcome.Block h10: investigation results a visual evaluation of the returned lithovue touch pc noted it was in good condition.A functional evaluation noted that the touch pc failed to provide a live image.There were no error messages and a time out did not occur.When a lithovue scope was plugged into the lithovue touch pc it could not detect the connection.The connection process was repeated many times with no success.The failure of is not powering on could not be confirmed.Based on the condition of the returned device, engineers determined that the conclusion of is not powering on was not replicated during functional testing, but another issue was detected.The failure mode observed could be caused because the touch pc could not detect the connection of the scope.Boston scientific has determined the most probable cause of this complaint is cause traced to component failure.Therefore, it can be concluded that component related was the most probable cause of the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Event Description
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It was reported to boston scientific corporation that a lithovue touch pc was attempted to be used on (b)(6) 2021.Touch pc could not power on, tried different socket and still would not power on.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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