Model Number M00550620 |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0902 captures the reportable event of reading inaccurate.
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Event Description
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Note: this report pertains to one of two alliance ii inflation/litho devices used during the same procedure.It was reported to boston scientific corporation that two alliance ii inflation/litho devices were used during a dilatation procedure performed on an unknown date.During the procedure, the pressure does not go up when the pressure is increased but goes down immediately.The same problem occurred with the second alliance ii inflation/litho device.The procedure was completed with another alliance ii inflation/litho device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0902 captures the reportable event of gauge reading inaccurately.
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Event Description
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Note: this report pertains to one of two alliance ii inflation/litho devices used during the same procedure.It was reported to boston scientific corporation that two alliance ii inflation/litho devices were used during a dilatation procedure performed on an unknown date.During the procedure, the pressure does not go up when the pressure is increased but goes down immediately.The same problem occurred with the second alliance ii inflation/litho device.The procedure was completed with another alliance ii inflation/litho device.There were no patient complications reported as a result of this event.Correction noted on december 20, 2023: the device type was corrected from an alliance ii handle inflation device to an alliance ii inflation syringe.
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Search Alerts/Recalls
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