Model Number 791-700 |
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 06/17/2021 |
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 during a flexible ureteroscopy procedure performed on (b)(6) 2021.During preparation, lithovue scope was connected to the monitor and booted up to windows screen.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: medical device problem code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned lithovue touch pc was analyzed, and a visual evaluation noted that there were some minor scratches on hte pc frame and the back panel, one standoff screw is missing on the dvi cable connector, and one interface box bracket mount screw is missing.A functional evaluation noted that the lithovue touch pc confirmed touch panel pc leds turn on.The lithovue touch pc display was blank at power on.The touch pc booted up to the blank screen instead of the application screen.The reported event was confirmed.This investigation is assigned a most probable conclusion code of cause traced to component failure.This conclusion was selected because the reason for when connecting the lithovue device to the screen, it did not open the boston scientific logo only windows was conformed during functional testing.The conclusion is acceptable because the analysis of the available information in the complaint did not find/reveal any other fault condition within the product.The evidence from the product record review did not identify a potential product quality issue or new patient harm.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use 91012672-02c / product label.
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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 during a flexible ureteroscopy procedure performed on (b)(6) 2021.According to the complaint, during preparation, lithovue scope was connected to the monitor and booted up to windows screen.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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