MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES; INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA

Model Number	FG-0202
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory device was used in a hysteroscopy procedure performed on (b)(6) 2017.According to the complainant, during preparation, when they plugged the pressure sensor into the console, the controller prompted a faulty pressure sensor message.The procedure was completed with another fluid management accessory device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
One symphion fluid management accessory device was received for analysis.Visual examination of the returned device revealed that there were no damage noted to the connector, cord or pressure sensor.Functional analysis revealed that it was possible for the pressure sensor connector to be inserted into the receptacle on the controller and for the pressure sensor to physically connect to the endoscope.However, the console displayed "pressure sensor test failed.Replace pressure sensor" error message during set-up.Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause.A review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a symphion fluid management accessory device was used in a hysteroscopy procedure performed on (b)(6) 2017.According to the complainant, during preparation, when they plugged the pressure sensor into the console, the controller prompted a faulty pressure sensor message.The procedure was completed with another fluid management accessory device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SYMPHION¿ TISSUE REMOVAL SYSTEM FLUID MANAGEMENT ACCESSORIES
• Common Device Name: INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6776346
• Report Number: 3005099803-2017-02341
• Device Sequence Number: 170412
• Product Code: PGT
• UDI-Device Identifier: 08714729863717
• UDI-Public: (01)08714729863717(17)20180512(10)0060944208
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2018
• Device Model Number: FG-0202
• Device Lot Number: 0060944208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 08/13/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1