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 Consequences Or Impact To Patient (2199)
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Event Date 07/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).The complainant indicated that the device was disposed 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 medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessories device was used during a hysteroscopic myomectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation, they received a faulty pressure sensor error.The procedure was completed with another symphion fluid management kit.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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