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 04/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Reported event of pressure sensor not detected.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¿ tissue removal system fluid management accessories device was used during a uterine polypectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation, the pressure sensor of the fluid management accessories was not detected by the controller and the controller displayed a message to replace the device.Another fluid management accessories device was used to complete the case with no issue.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 was received for analysis.A functional evaluation of the device revealed that it was possible to insert the pressure sensor connector into the receptacle on a symphion controller, and for the pressure sensor to physically connect to the endoscope.However, the controller displayed the following error during set up: "pressure sensor test failed.Replace pressure sensor." the complaint was confirmed.A review and analysis of all available information failed to indicate a root cause or probable root cause for the failure observed.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
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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 device was used during a uterine polypectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation, the pressure sensor of the fluid management accessories was not detected by the controller and the controller displayed a message to replace the device.Another fluid management accessories device was used to complete the case with no issue.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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