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
Device Inoperable (1663)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/31/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.Manufacturer: (b)(4).Device component code relates to problem code for the reported event of pressure sensor not detected.The complainant indicated that the device was disposed 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 medwatch will be filed.
|
|
Event Description
|
This manufacturer report pertains to one of two devices used in the same procedure.Manufacturer report # 3005099803-2017-02791 pertains to the first symphion fluid management accessory and manufacturer report # 3005099803-2017-02792 to the second symphion management accessory.It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory device was used during a polypectomy procedure performed on (b)(6) 2017.According to the complainant, during preparation, they received a faulty pressure sensor error message (captured in mfr report # 3005099803-2017-02791).A second fluid management accessory device was used but the same thing happened (captured in mfr report # 3005099803-2017-02792).The procedure was completed with a third symphion fluid management kit.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be fine.
|
|
Search Alerts/Recalls
|
|
|