BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
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Model Number FG-0202 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/10/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device has been disposed of and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 symphion fluid management accessories device was used in the uterus during a hysteroscopy procedure performed on (b)(6) 2015.According to the complainant, during preparation, the pressure sensor failed and the symphion controller displayed a message to replace the pressure sensor.The procedure was completed using another symphion fluid management accessories device.Attempts to obtain additional patient and procedure information have been unsuccessful.If any further relevant information is received, a supplemental mdr will be filed.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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