BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
|
Back to Search Results |
|
Model Number FG-0202 |
Device Problem
Communication or Transmission Problem (2896)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/25/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 recognized by controller.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.
|
|
Event Description
|
It was reported to boston scientific corporation that a symphion fluid management accessories device was used during a hysteroscopy and myomectomy procedure performed on (b)(6) 2016.According to the complainant, during preparation for the procedure, the pressure sensor of the device was not recognized by the controller upon connection.The user disconnected and reconnected the sensor to the controller, as well as power cycled the controller, but the pressure sensor remained unrecognized.The procedure was completed with another symphion fluid management accessories device.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.
|
|
Search Alerts/Recalls
|
|
|