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
Communication or Transmission Problem (2896)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).(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 during a uterine polypectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation for the procedure, the pressure sensor of the fluid management accessories was not detected by the controller.The procedure was completed using another fluid management accessories device.There were no patient complications as a result of this 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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