Model Number 791-100 |
Device Problems
Failure to Power Up (1476); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/17/2020 |
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 used in a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue touch pc was used and there was no image on the screen.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
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Manufacturer Narrative
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Block h10: device problem code 3191 is being used to capture the reportable issue of cancelled procedure.Block h10: investigation results.An inspection of the returned lithovue touch pc showed no discrepancy.A functional evaluation noted that the lithovue touch pc confirmed there is a display on the touch panel.The monitor was left running for over an hour, rebooted, and the scope was unplugged.When the touch pc was powered on, it showed a clear live image.The test was done three times.The reported event of device does not turn on was not confirmed.This investigation is assigned a most probable conclusion code of no problem detected.This conclusion was selected because the reason for the device definitely does not turn on could not be duplicated/replicated during functional testing.It can be concluded that the product operates as intended with no issues.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 used in a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the lithovue touch pc was used and it did not have an image.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
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Search Alerts/Recalls
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