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 05/05/2016 |
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 tissue removal system fluid management accessories kit was used during a uterine resection procedure performed on (b)(6) 2016.According to the complainant, during preparation, the connection of the pressure sensor to the controller and scope was confirmed to be secure; however, the controller displayed an error message and would not read the pressure sensor.The procedure was completed with 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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Search Alerts/Recalls
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