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
Communication or Transmission Problem (2896)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, it was reported that the device was not expired.(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 tissue resection procedure performed on (b)(6) 2016.According to the complainant, during preparation for the procedure, the symphion controller displayed a "pressure sensor failed" error message.The connections to the scope and controller were confirmed to be secure.The controller was restarted; however, setup would not pass the pressure sensor test.The procedure was completed using the same controller and 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 fine.
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