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 04/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however ,it was reported that the patient was over the age of 18.Reported event of pressure sensor not detected.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 was used during an intra-uterine resection procedure performed on (b)(6) 2016.According to the complainant, during preparation, the components of the fluid management accessories were plugged into the controller; however, the controller displayed a "no pressure sensor detected" error.The fluid management accessories kit was replaced with another of the same and the procedure was successfully completed.There were no patient complications reported as a results of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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