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 05/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 symphion fluid management accessories kit was to be used during a hysteroscopic polypectomy procedure in the uterus performed on (b)(6) 2016.According to the complainant, during preparation, the pressure sensor test failed and the controller displayed an error message instructing to "replace pressure sensor." the procedure was completed using another symphion fluid management accessories kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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Manufacturer Narrative
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One symphion fluid management accessory device was returned for investigation.During analysis.The pressure sensor connector could be insert into the receptacle on the controller.Additionally, the pressure sensor could be physically connected to the endoscope.However, during setup, the controller displayed a "pressure sensor test failed.Replace pressure sensor" error.The analysis of the product and all available information fails to indicate a root cause or probable root cause for this complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Event Description
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It was reported to boston scientific corporation that a symphion fluid management accessories kit was to be used during a hysteroscopic polypectomy procedure in the uterus performed on (b)(6) 2016.According to the complainant, during preparation, the pressure sensor test failed and the controller displayed an error message instructing to "replace pressure sensor." the procedure was completed using another symphion fluid management accessories kit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
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